RAIN Sheath Transradial 506610SRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705032078948), received between Jan 22, 2020 and Oct 17, 2025 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, A 6F 10 CM RAIN SHEATH TRANSRADIAL HYDROPHILIC THIN-WALLED INTRODUCER SHEATH UNRAVELED AND COULD NOT BE INSERTED. THERE WAS NO REPORTED PATIENT INJURY. THE EXACT EVENT DATE AND THE LOT NUMBER WERE NOT PROVIDED. ONE IMAGE WAS PROVIDED, AND IT SHOWS WHAT APPEARS TO BE THE DISTAL END OF THE CANNULA OF A CATHETER SHEATH INTRODUCER WITH A GRAY VESSEL DILATOR INSERTED THROUGH IT. THE DISTAL TIP OF THE CANNULA APPEARS DAMAGED; HOWEVER, IT CANNOT BE DETERMINED IF THE TIP IS FRAYED, SPLIT, TORN, OR ACCORDIONED. THE AFFECTED DEVICE HAS BLOODY RESIDUE ON IT, SUGGESTING AN ATTEMPT WAS MADE TO INSERT THE DEVICE INSIDE A PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324290 ↗
• MalfunctionAug 8, 2025Fracture; Stretched; Unraveled Material; Fracture; Stretched; Unraveled Material

  AS REPORTED, THE 6F 10CM TRANS-RADIAL RAIN SHEATH INTRODUCER WOULD NOT GO INTO RADIAL ARTERY. THE DEVICE BUNCHED UP. THE PROCEDURE WAS COMPLETED BY SWITCHING TO THE FEMORAL APPROACH. THERE WERE NO REPORTS OF PATIENT INJURY. THE INSERTION SITE WAS MODERATELY CALCIFIED AND NOT TORTUOUS. THE DEVICE WAS FLUSHED PRIOR TO USE, AND THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO PATIENT-SPECIFIC ANATOMICAL ANOMALIES NOTED AT THE INSERTION SITE. INSERTION DIFFICULTIES WERE EXPERIENCED AT THE PROXIMAL SECTION WHILE TRYING TO INSERT THE SHEATH. THERE WERE NO DAMAGES FOUND ON THE DEVICE OR ITS PACKAGING PRIOR TO OPENING. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE IFU. ALTHOUGH, THE CATHETER SHEATH INTRODUCER (CSI) WAS ONLY DIPPED AND NOT SOAKED OR WIPED DOWN WITH A WET GAUZE. THE USER WAS TRAINED IN THE USE OF THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDENDUM: PER PE FINDINGS, THE MINI GUIDEWIRE IS INSERTED INTO THE NEEDLE PRESENTING AN UNRAVEL AND A FRACTURED/SEPARATED CONDITION ON THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754161 ↗
• MalfunctionNov 1, 2024

  WHEN REMOVING A DIAGNOSTIC CATHETER FROM THE RIGHT RADIAL ARTERY, THE CATHETER GOT STUCK AND WOULD NOT COME OUT OF THE SHEATH. ULTIMATELY THE ENTIRE SHEATH WAS REMOVED, AND OBVIOUS DAMAGE WAS APPRECIATED TO THE SHEATH. THIS WAS ALREADY THE PLANNED END OF THE PROCEDURE; NO APPARENT HARM WAS OBSERVED. A RADIAL BAND WAS PLACED TO RIGHT WRIST AS USUAL PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586726 ↗
• MalfunctionJan 11, 2024Partial Blockage; Partial Blockage

  AS REPORTED, THE DILATOR OF A 6F 10CM RAIN TRANS RADIAL CATHETER SHEATH INTRODUCER (CSI) COULD NOT BE FLUSHED DUE TO AN OBSTRUCTION WITHIN THE DILATOR. AN IMAGE OF THE 6F RAIN CSI DILATOR WAS PROVIDED. IN THE IMAGE, AN UNKNOWN GUIDEWIRE CAN BE SEEN EXITING THE DISTAL TIP OF THE 6F RAIN CSI DILATOR. AN UNKNOWN SUBSTANCE CAN BE SEEN AT THE TIP OF THE GUIDEWIRE AS IT EXITED THE DISTAL TIP OF THE 6F RAIN CSI DILATOR. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE DEVICE WAS NEVER USED INSIDE OF THE PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499102 ↗
• MalfunctionOct 27, 2023Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE TIP OF THE DILATOR OF A 6F 10CM SF RAIN SHEATH TRANS-RADIAL THIN-WALLED SHEATH WAS CRUSHED, UPON OPENING. IT WAS PURGED AND THE SOLUTION CAME OUT FROM THE SIDE. THEREFORE, THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RAIN SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES NOTED ON THE PACKAGING OR SHIPPING BOX OF THE DEVICE. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. ADDENDUM: PRODUCT EVALUATION SHOWS A FRAYED CONDITION ON THE DISTAL TIP OF THE VESSEL DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023477 ↗
• MalfunctionSep 11, 2023Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, A 6F 10CM RAIN SHEATH RADIAL CATHETER SHEATH INTRODUCER (CSI) COULD NOT BE INTRODUCED INTO THE RADIAL ARTERY BUT "SCRATCHED" OFF. THE COATING OF THE SHEATH PULLED OFF AND PUSHED UP. THE PROCEDURE WAS COMPLETED USING ANOTHER NON CORDIS CSI. THERE WAS NO REPORTED PATIENT INJURY. THE CSI WAS SOAKED; IT WAS NOT WIPED DOWN WITH WET GAUZE. THE PATIENT DID NOT HAVE ANY UNUSUALLY TOUGH SKIN, SCAR TISSUE, OR CONTRACTURES OF THE JOINT. THE PROCEDURE WAS COMPLETED USING ANOTHER NON CORDIS CSI. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719722 ↗
• InjuryAug 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 6F 10CM TRANSRADIAL RAIN SHEATH SEPARATED ABOUT 1CM FROM THE HUB INSIDE A VEIN WHEN THE PHYSICIAN WENT TO REMOVE THE SHEATH. A SURGEON WAS CALLED, AND THE PATIENT HAD A CUT-DOWN PROCEDURE TO REMOVE THE REMAINING CANNULA OF THE SHEATH. THE PROCEDURE WAS ABORTED DUE TO THE COMPLICATION. THE PATIENT IS DOING WELL AFTER THE PROCEDURE. A PHYSICIAN WENT TO GAIN RIGHT RADIAL ACCESS AND STUCK THE VEIN. THE PHYSICIAN THEN PROCEEDED AND PLACED A 6F RAIN TRANSRADIAL SHEATH INSIDE THE VEIN. THE PHYSICIAN THEN TRIED TO GAIN ACCESS TO THE RIGHT RADIAL ARTERY AND DID SUCCESSFULLY. A 6F RAIN SHEATH WAS PLACED INSIDE OF THE ARTERY. AN UNKNOWN J-WIRE WAS USED. GETTING ARTERIAL ACCESS POTENTIALLY NICKED THE VENOUS SHEATH IN PLACE AND THE INTEGRITY OF THE CANNULA "MAY HAVE BEEN DAMAGED CAUSING THE BREAK IN THE SHEATH UPON REMOVAL". THERE WERE NO DAMAGES NOTED TO THE DEVICE PRIOR TO USING IT. THERE WAS NO CALCIFICATION OR TORTUOSITY AT THE INSERTION VESSEL SITE. THERE WERE NO SPECIFIC PATIENT ANATOMICAL ANOMALIES NOTED AT THE INSERTION SITE. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN,

  Patient problems: Foreign Body In Patient

  MAUDE report 17592821 ↗
• MalfunctionJun 27, 2023Crack; Crack

  AS REPORTED, A 6F RAIN SHEATH TRANSRADIAL INTRODUCER WAS USED AND WHEN IT WAS PULLED, THE DISTAL END WAS CRACKED. THE DAMAGE WAS NOTICED UNTIL AFTER THE CASE WAS COMPLETED AND THE SHEATH WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS BEING USED IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) USING RIGHT RADIAL ACCESS (RRA). THE PHYSICIAN DID NOT NOTICE ANYTHING ¿ODD¿ UPON INSERTION. THE DEVICE WAS STORED AND OPENED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ISSUES REMOVING SHEATH FROM THE PACKAGING. THE DEVICE WAS NOT CRACKED PRIOR TO INSERTION. THERE WAS NO CALCIFICATION NOTED. VESSEL/LESION CHARACTERISTIC WERE REPORTED AS DOMINANT RIGHT CORONARY ARTERY (RCA); PROXIMAL PORTION THIRTY-PER CENT (30%) TUBULAR NARROWING WITH CALCIFICATION BIFURCATING IN PATENT DUCTUS ARTERIOSUS (PDA) AND LARGE POSTEROLATERAL SYSTEM WITH MODERATE DISEASE. VESSEL TORTUOSITY WAS NOT NOTED IN THE REPORT; DISTAL RCA WAS MODERATELY CALCIFIED WITH NINETY PER-CENT (90%) STENOSIS. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE CSI WAS SOAKED IN STERILE HEPARINIZED SALINE OR SIMILAR ISOTONIC SOLUTION DURING THE SAMPLE PREP STEP PER THE INSTRUCTIONS FOR USE (IFU)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207767 ↗
• MalfunctionMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, A 6F,10CM RAIN SHEATH DID NOT WANT TO INSERT ALL THE WAY WHILE ULTRASOUND GUIDED ACCESS TO THE RADIAL ARTERY WAS PERFORMED. WHEN THEY TRIED TO DRAW BACK BLOOD, AIR AND CLOT WERE OBSERVED IN THE SHEATH. THE DECISION WAS MADE TO ABORT THAT SITE AND TRY MORE DISTAL CLOSER TO THE WRIST. THE PHYSICIAN NOTED EVENLY SPACED ¿KINKS¿ IN SHEATH, AND THE PHYSICIAN ASKED FOR 6 F RAIN SHEATH WHICH WENT IN AND PERFORMED PERFECTLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS FLUSHED PRIOR TO USE. THE VESSEL DILATOR WAS SNAPPED INTO PLACE AT THE HUB. THERE WERE NO PATIENT SPECIFIC ANOMALIES NOTED AT THE INSERTION SITE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THE CSI WAS SOAKED AND INSERTED HALF-WAY BEFORE EXPERIENCING INSERTION DIFFICULTIES. THE PATIENT HAD NOT RECEIVED ADEQUATE ANTICOAGULATION SINCE THE SHEATH WAS BEING INSERTED. THE USER WAS TRAINED TO THE DEVICE. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16961821 ↗
• MalfunctionApr 21, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, A 6F 10CM SW RAIN SHEATH TRANS-RADIAL SHEATH INTRODUCER ACCORDIONED AND GOT STUCK IN THE PATIENT'S ARM. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16784913 ↗
• MalfunctionMar 14, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, THERE WAS INCREASED FRICTION ON INSERTION AND REMOVAL OF A 6F 10CM SW RAIN CATHETER SHEATH INTRODUCER (CSI) AND IT WAS SO APPARENT THAT THE COATING FELT AS IF IT WAS NOT PRESENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540014 ↗
• MalfunctionMar 14, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, THERE WAS INCREASED FRICTION ON INSERTION AND REMOVAL OF A 6F 10CM SW RAIN CATHETER SHEATH INTRODUCER (CSI) AND IT WAS SO APPARENT THAT THE COATING FELT AS IF IT WAS NOT PRESENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539970 ↗
• MalfunctionMar 14, 2023Difficult to Remove; Difficult to Remove

  AS REPORTED, THERE WAS INCREASED FRICTION ON INSERTION AND REMOVAL OF A 6F 10CM SW RAIN CATHETER SHEATH INTRODUCER (CSI) AND IT WAS SO APPARENT THAT THE COATING FELT AS IF IT WAS NOT PRESENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539861 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN INDICATED THAT POST PROCEDURE THERE WAS BLEEDING FROM THE ACCESS SITE OF THE 6F 10CM TRANSRADIAL RAIN SHEATH. A RADIAL COMPRESSION BAND WAS APPLIED AND WHEN THEY CHECKED ON THE PATIENT THERE WAS BLOOD POOLING. THEY REATTACHED THE BAND BUT AGAIN HAD BLEEDING. DOCTOR STATED THE ONLY FACTOR HE COULD THINK OF WAS THAT HE IS TRAINING WITH THE NEW RAIN SHEATH (THIS WAS THE FIRST ONE HE TRIED). THE DEVICE WAS STORED AS PER THE LABELING AND WAS OPENED IN A STERILE FIELD. IT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14337836 ↗
• MalfunctionFeb 8, 2022Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, WHEN PHYSICIAN INSERTED THE 6F 10CM RAIN SHEATH INTO THE RADIAL ARTERY, THE HYDROPHILIC COATING BUCKLED/CRIMPLED. THE COATING OF THE DEVICE WAS NOTED TO HAVE BUCKLED IN THE BODY/SHAFT WITH NO COATING PEELING AWAY FROM THE DEVICE IN WHICH THE DEVICE COULD NOT BE USED. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PHYSICIAN FOLLOWED ALL THE CORRECT STEPS PRIOR TO SHEATH INSERTION, DILATOR CLICKED INTO THE SHEATH, SHEATH MADE SLOPPY, NOT LEFT TO DRY. THIS OCCURRED AS THE SHEATH WAS BEING INSERTED INTO THE PATIENT; HOWEVER, THE SHEATH DID NOT PASS THE ENTRY POINT. THE DEVICE WAS STORED IN THE ORIGINAL BOX ON THE COUNTERTOP. NO ANOMALIES WERE NOTED, THE CONSULTANT DID MENTION THAT THE SHEATH HYDROPHILIC COATING HAS A ROUGH SURFACE COMPARED TO COMPETITORS. THE DEVICE WAS PREPPED PER THE IFU AND THE COATING WAS ACTIVATED TWICE. THERE WAS NO DIFFICULTY NOTED DURING PREP OF THE DEVICE. THE LESION DID NOT HAVE ANY CALCIFICATION. THE VESSEL WAS NOT PRE-DILATED. THE SHEATH WAS NOT TORQUED AGAINST RESISTANCE AND UNUSUAL FORCE WAS NOT NEEDED DURING THE PROCEDURE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. THE CASE WAS COMPLETED WITH A SKIN NICK AND TAPE WAS US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483009 ↗
• MalfunctionNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UPON INSERTION OF THE 6F10CM SW RADIAL RAIN SHEATH, THE CUSTOMER SAID THE CAP BECAME DISENGAGED FROM THE SHEATH AND WAS NOT ABLE TO BE REATTACHED. THE INNER PLASTIC VALVE CAME LOOSE FROM THE HUB SO THE PHYSICIAN COULD NOT SNAP THE CAP BACK ON. ANOTHER RAIN SHEATH WAS USED WHICH WORKED FINE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803658 ↗
• MalfunctionSep 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE HYDROPHILIC COATING OF A 6F 10CM TRANS-RADIAL RAIN SHEATH STRIPPED OFF UPON INSERTION FOR A DIAGNOSTIC PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED IN THE LAB PER THE INSTRUCTIONS FOR USE (IFU) IN A CLIMATE-CONTROLLED ENVIRONMENT. THE DEVICE WAS STORED BEFORE USE FOR LESS THAN A MONTH. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGING. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS OPENED IN A STERILE FIELD. THE DAMAGE WAS NOTICED AFTER INSERTION INTO THE PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED DURING THE PREP OF THE DEVICE. THE DEVICE WAS WET WITH A SYRINGE BEFORE INSERTION. THE DEVICE WAS EXPOSED TO AIR FOR LESS THAN A MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER SWITCHING TO A NON-CORDIS SHEATH. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12454963 ↗
• MalfunctionJul 29, 2021Stretched; Unraveled Material; Stretched; Unraveled Material

  AS REPORTED, AFTER SUCCESSFUL PUNCTURE WHILE RETRACTING THE PUNCTURE NEEDLE IT WAS NOTICED THAT THE PROXIMAL END OF THE MINI GUIDEWIRE (GW) OF 6F 10CM STAINLESS STEEL WIRE (SW) TRANSRADIAL RAIN SHEATH INTRODUCER WAS UNRAVELED/STRETCHED. IN ORDER TO PROCEED WITH THE PROCEDURE, THE TEAM DECIDED TO CUT OFF THE FRAYED PART OF THE MINI GW. INSERTION OF THE SHEATH OVER THE REMAINDER OF THE MINI GW INTO THE VESSEL WORKED VERY WELL. PROCEDURE COULD BE FINISHED. THERE WAS NO REPORTED PATIENT INJURY. THE TRANSRADIAL RAIN SHEATH INTRODUCER WAS PREPPED AS PER THE PER INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. DURING THE SAMPLE PREP STEP (PER IFU), THE CSI WAS FLUSHED AND WIPED DOWN WITH A WET GAUZE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247106 ↗
• MalfunctionJun 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED. A 6F 10CM TRANSRADIAL RAIN SHEATH INTRODUCER HAD A MANUFACTURING DEFECT NEXT TO THE INTRODUCER VALVE WHERE IT ALSO HAD A FOLD/KINK. IN ADDITION, THE PRODUCT WAS ALSO SEPARATED BEFORE USE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED IN THE CATH LAB, FOR ONE MONTH. THE PRODUCT WAS STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) CASE. THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO OPENING THE PACKAGE. THERE WAS NO DIFFICULTY REMOVING THE DEVICE FROM THE STERILE PACKAGING. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995642 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 6F 10CM STEEL WIRE (SW) TRANS-RADIAL RAIN SHEATH INTRODUCER WAS PLACED IN SALINE BATH TO ACTIVATE HYDROPHILIC COATING AND UPON REMOVAL, THE SCRUB TECH RUBBED FINGERS ALONG THE SHEATH, HOWEVER, A SIGNIFICANT AMOUNT OF HYDROPHILIC COATING CAME OFF OF THE SHEATH. THEY OPENED A SECOND TRANS-RADIAL RAIN SHEATH, SAME LOT NUMBER AND THE EXACT SAME THING HAPPENED. THE HYDROPHILIC COATING SHEARED OFF UPON REMOVAL FROM THE SALINE BATH. THE DAMAGE WAS NOTICED ONCE THE SHEATH WAS ADVANCED OVER WIRE AND, IN THE VESSEL,, THERE WAS HYDROPHILIC COATING EVIDENT AT THE INSERTION SITE. A SIGNIFICANT AMOUNT COATING WAS REPORTED TO COME OFF FROM DISTAL TO THE PROXIMAL TIP. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE OPENED IN STERILE FIELD. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE SEEMED TO BE NORMAL WITH NO ANOMALIES AFTER REMOVAL FROM PACKAGE. THE HYDRATION OF THE SHEATH LOOKED FINE WHEN REMOVED FROM THE PACKAGE. THE SHEATH WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED DURING THE PREP OF THE DEVICE. THE DEVICE WAS USED IN THE PATIENT. THE OPERATOR WAS A TRAINED TRANS-RADIAL RAIN SHEATH USER. THE DEV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943523 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 6F 10CM STEEL WIRE (SW) TRANS-RADIAL RAIN SHEATH INTRODUCER WAS PLACED IN SALINE BATH TO ACTIVATE HYDROPHILIC COATING AND UPON REMOVAL, THE SCRUB TECH RUBBED FINGERS ALONG THE SHEATH, HOWEVER, A SIGNIFICANT AMOUNT OF HYDROPHILIC COATING CAME OFF OF THE SHEATH. THEY OPENED A SECOND TRANS-RADIAL RAIN SHEATH, SAME LOT NUMBER AND THE EXACT SAME THING HAPPENED. THE HYDROPHILIC COATING SHEARED OFF UPON REMOVAL FROM THE SALINE BATH. THE DAMAGE WAS NOTICED ONCE THE SHEATH WAS ADVANCED OVER WIRE AND, IN THE VESSEL,, THERE WAS HYDROPHILIC COATING EVIDENT AT THE INSERTION SITE. A SIGNIFICANT AMOUNT COATING WAS REPORTED TO COME OFF FROM DISTAL TO THE PROXIMAL TIP. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WERE OPENED IN STERILE FIELD. THE DEVICE WAS STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE SEEMED TO BE NORMAL WITH NO ANOMALIES AFTER REMOVAL FROM PACKAGE. THE HYDRATION OF THE SHEATH LOOKED FINE WHEN REMOVED FROM THE PACKAGE. THE SHEATH WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED DURING THE PREP OF THE DEVICE. THE DEVICE WAS USED IN THE PATIENT. THE OPERATOR WAS A TRAINED TRANS-RADIAL RAIN SHEATH USER. THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943508 ↗
• MalfunctionApr 19, 2021Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn

  AS REPORTED, THE 6F 10CM STAINLESS STEEL WIRE (SW) TRANSRADIAL RAIN SHEATH INTRODUCER HAD SOME KINKS AND WAS FRAYED AT THE END. THE SHEATH WENT IN JUST FINE BUT WAS UNABLE TO REMOVE THE DILATOR AND UNKNOWN WIRE. STAFF MEMBER SAID IT WAS STUCK INSIDE THE BODY. THE SHEATH AS A WHOLE INCLUDING THE DILATOR WERE THEN REMOVED. PRESSURE WAS HELD AND A NEW ACCESS WITH A NEW UNKNOWN SHEATH WAS MADE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11688734 ↗
• MalfunctionMar 8, 2021Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  AS REPORTED, THE PHYSICIAN INSERTED A 6F 10CM TRANSRADIAL RAIN SHEATH INTRODUCER INTO THE PATIENT¿S RADIAL ARTERY AND THEY SAW SOMETHING LIKE THE TOP PART OF THE CANNULA CAME LOOSE AND WAS MOVING UP IN A CONDENSED WAY. THERE WAS DIFFICULTY INSERTING THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE FAULTY RAIN SHEATH REMOVED AND REPLACED IT WITH ANOTHER RAIN SHEATH AND THAT ONE WORKED VERY WELL. THE DEVICE WAS INTENDED TO BE USED IN A CATHETERIZATION PROCEDURE. THE PRODUCT WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE DEVICE WAS CHECKED AND APPEARED NORMAL PRIOR TO USE. THERE WAS NO DIFFICULTY PREPPING THE DEVICE AS THERE WAS NO DIFFICULTY FLUSHING THE SHEATH PRIOR TO USE. NO CALCIFICATIONS AT THE RADIAL ARTERY OR AT THE PUNCTURE SITE. THE DEVICE WILL BE RETURNED FOR EVALUATION. PHOTOS ARE PROVIDED AND AVAILABLE FOR REVIEW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436937 ↗
• MalfunctionJul 9, 2020Difficult to Remove; Difficult to Remove

  THE VALVE OF A 6F 10CM STEEL WIRE (SW) RAIN SHEATH INTRODUCER LEAKED A LOT. THE PHYSICIAN DID NOT THINK THE DEVICE SO HYDROPHILIC AND THE GUIDEWIRE SO HARD. THERE WAS ALSO DIFFICULTY INSERTING THE DILATOR AND REMOVING IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE CSI SUBSTITUTED FOR AN AVANTI +. THERE WAS NO PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE PRODUCT APPEARED TO LOOK NORMAL WHEN TAKEN FROM ITS PACKAGING APART FROM THE DILATOR THAT LOOKED SOMEHOW DEFECTIVE. THE DILATOR WAS SLIGHTLY CROOKED. THE ACCESS SITE WAS NOT CALCIFIED AND DID NOT HAVE A HIGH DEGREE OF STENOSIS. THERE WAS NO DIFFICULTY FLUSHING THE DEVICE BUT THE DILATOR WAS VERY DIFFICULT TO INSERT AND A BIT AFTER NOT MANAGING TO INSERT IT, EXCESSIVE FORCE WAS USED.. THE ACCESS SITE LOCATION WAS THE RADIAL ARTERY AND THE PROCEDURE BEING PERFORMED WAS A REGULAR ANGIOGRAPHY. THE GUIDE WIRE WAS NOT INCLINED WHILE INSERTING VIA THE VALVE OF THE SHEATH. THE CSI WAS SOAKED AND FLUSHED IN STERILE HEPARINIZED SALINE OR SIMILAR ISOTONIC SOLUTION TO ACTIVATE THE HYDROPHILIC COATING. THE VESSEL DILATOR WAS INSERTED WITH DIFFICULTY THROUGH THE CSI¿S HEMOSTASIS VALVE, BUT IT CLICKED, SNAPPING IT INTO PLACE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10251903 ↗
• MalfunctionJan 22, 2020Partial Blockage; Partial Blockage

  AS REPORTED, THE DILATOR OF THE 6F 10CM RADIAL RAIN SHEATH STAINLESS STEEL WIRE (SW) HAD NO DISTAL HOLE. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS CLINICALLY USED BY THE PATIENT. THE DEVICE MALFUNCTION WAS OBSERVED DURING PREP. THE DEVICE WAS PREPPED AND USED AS PER THE IFU. THE DEVICE LOOKED NORMAL WHEN TAKEN FROM ITS PACKAGING AND NO DAMAGE NOTED. THE DILATATOR WAS LIKELY PERFECT, EXCEPT FOR THE MISSING HOLE. THE USER STRONGLY PUSHED THE GUIDEWIRE INSIDE TO CREATE A HOLE AT THE DISTAL END THEN A MICROSCOPIC PIECE OF PLASTIC WENT OUT. OTHER ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9616019 ↗