Micropuncture G43870Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00827002438705), received between Nov 12, 2014 and Apr 25, 2025 — classified as 1 death, 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 25, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED BY A DISTRIBUTOR, WHILE UNPACKING A SHIPPING BOX, THE BOTTOM OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S STERILE PACKAGE WAS NOTED TO BE UNSEALED. THERE WAS NO IMPACT TO THE END USER OR ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908285 ↗
• MalfunctionFeb 19, 2025Unraveled Material; Unraveled Material

  AS REPORTED, WHILE OBTAINING ULTRASOUND-GUIDED ACCESS IN THE RIGHT BASILIC VEIN FOR A RIGHT HEART CATHETERIZATION, A MICROPUNCTURE TRADITIONLESS ACCESS SET¿S WIRE UNRAVELED. PER THE REPORTER, THE ACCESS SITE WAS NORMAL, AND BLOOD RETURN WAS NOTED UPON INSERTION OF THE 21-GAUGE NEEDLE, PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. RESISTANCE WAS REPORTEDLY ENCOUNTERED UPON ADVANCEMENT OF THE WIRE THROUGH THE NEEDLE AND THE USER DECIDED TO WITHDRAW THE WIRE, AT WHICH POINT IT WAS ¿SHEARED¿ BY THE NEEDLE AND UNRAVELED. THE DEVICE WAS REMOVED AND ANOTHER ¿TRADITIONAL PUNCTURE SET¿ WAS USED FOR FEMORAL ACCESS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21414404 ↗
• MalfunctionJan 23, 2025Unraveled Material; Unraveled Material

  AS REPORTED, DURING AN OPEN-HEART PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET¿S WIRE UNRAVELED. ULTRASOUND-GUIDED ACCESS WAS OBTAINED IN THE FEMORAL ARTERY USING THE 21-GAUGE NEEDLE INCLUDED IN THE SET, AND BLOOD RETURN WAS NOTED. THE ACCESS SITE WAS CALCIFIED. UPON ADVANCEMENT OF THE WIRE INTO THE NEEDLE, THE WIRE BECAME STUCK WITHIN THE NEEDLE. THE PHYSICIAN ASSISTANT ATTEMPTED TO PULL THE WIRE BACKWARDS THROUGH THE NEEDLE; HOWEVER, IT COULD NOT BE REMOVED. THE USER THEN REMOVED THE WIRE AND NEEDLE TOGETHER, NOTING THAT THE WIRE HAD UNRAVELED ¿DISTAL¿ TO THE NEEDLE. SECONDARY ACCESS WAS OBTAINED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219433 ↗
• MalfunctionNov 1, 2024Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586497 ↗
• MalfunctionNov 14, 2023Break; Break

  AS REPORTED, DURING A LOWER EXTREMITY ANGIOGRAM, A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S WIRE "BROKE". ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, USING ULTRASOUND GUIDANCE, AND BLOOD RETURN WAS NOTED PRIOR TO ADVANCEMENT OF THE WIRE. THE ACCESS SITE WAS SCARRED AND CALCIFIED. RESISTANCE WAS NOT ENCOUNTERED UPON INSERTION OR REMOVAL OF THE WIRE OR ANY DEVICE COMPONENT. THE USER PULLED THE WIRE BACKWARDS THROUGH THE NEEDLE, AT WHICH POINT THE WIRE BROKE UPON REMOVAL. A NEW MICROPUNCTURE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130627 ↗
• MalfunctionNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A CORONARY ANGIOGRAM, THE OUTER CANNULA OF A MICROPUNCTURE TRANSITIONLESS ACCESS SET'S HUB SEPARATED. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY. THE ACCESS SITE WAS NORMAL, AND RESISTANCE WAS NOT ENCOUNTERED DURING INSERTION OR REMOVAL OF ANY DEVICE COMPONENT. THE COMPLAINT DEVICE WAS USED TO FACILITATE PLACEMENT OF A LARGER WIRE GUIDE. THE MICROPUNCTURE WIRE WAS NOT REMOVED THROUGH THE ENTRY NEEDLE. DURING INSERTION OF THE DEVICE, THE OUTER CANNULA'S HUB SEPARATED, LEAVING NO SHAFT MATERIAL REMAINING IN THE HUB. THE SHAFT REMAINED IN THE PATIENT OVER THE WIRE GUIDE; HOWEVER, MOSQUITO FORCEPS WERE USED TO GRAB THE SHAFT AND RETRIEVE IT FROM THE PATIENT OVER THE WIRE GUIDE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049200 ↗
• MalfunctionMar 27, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16622277 ↗
• InjuryMar 1, 2023Break; Unraveled Material; Break; Unraveled Material

  AS REPORTED, DURING A HEART CATHETERIZATION, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED IN THE PATIENT. NEEDLE ACCESS WAS OBTAINED IN THE RIGHT INTERNAL JUGULAR VEIN AND THE MICROPUNCTURE WIRE WAS INSERTED. UPON REMOVAL OF THE WIRE GUIDE, THE TIP SHEARED OFF IN THE PATIENT. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL VEIN AND A SNARE WAS USED TO RETRIEVE THE WIRE TIP WITHOUT INJURY OR FURTHER COMPLICATION. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE ON 24FEB2023, THE WIRE WAS ELONGATED/UNRAVELED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16460906 ↗
• InjurySep 29, 2022Break; Break

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED AT THE "JUNCTION", WITHIN THE PATIENT. THE WIRE FRAGMENT WAS SNARED FROM THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15508656 ↗
• DeathOct 3, 2021Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Cerebral Edema; Foreign Body In Patient; Intracranial Hemorrhage; Stroke/CVA

  MAUDE report 12566588 ↗
• MalfunctionMar 12, 2020Material Frayed; Material Frayed

  INITIALLY REPORTED, DURING A NEPHRECTOMY, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET "SHREDDED". THE WIRE REPORTEDLY BECAME STUCK IN THE NEEDLE AND SUBSEQUENTLY SEPARATED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH 3500A ON 06MAR2020. THE PROCEDURE WAS A LAPAROSCOPIC HAND ASSISTED LEFT RADICAL NEPHRECTOMY. WHILE ATTEMPTING TO GAIN LARGE BORE VENOUS ACCESS IN THE RIGHT ANTECUBITAL SPACE, THE NEEDLE WAS SUCCESSFULLY PLACED; HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE WIRE GUIDE WAS THREADED INTO THE VEIN. REPORTEDLY, AS THE WIRE GUIDE WAS PULLED, IT APPEARED TO SHEAR AND WAS FRAYED. THE WIRE AND NEEDLE WERE THEN REMOVED TOGETHER. A VASCULAR CONSULT WAS OBTAINED TO VIEW FLUOROSCOPIC IMAGES IN ORDER TO CONFIRM THERE WERE NO FRAGMENTS IN THE PATIENT. THE ORIGINAL SURGERY WAS COMPLETED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823336 ↗
• MalfunctionMar 2, 2020Material Frayed; Physical Resistance/Sticking

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION, TYPE 2 DIABETES, CHRONIC HEART FAILURE AND ATRIAL FIBRILLATION UNDERGOING LAPAROSCOPIC HAND ASSISTED LEFT RADICAL NEPHRECTOMY. WHILE ATTEMPTING TO GAIN LARGE BORE VENOUS ACCESS IN THE RIGHT AC SPACE THE NEEDLE WAS SUCCESSFULLY PLACED BUT WHEN THE GUIDE WIRE WAS THREADED INTO THE VEIN, THERE WAS RESISTANCE. WHEN THE WIRE WAS REMOVED, IT WAS FRAYED. NO HARM TO PATIENT. PER ANESTHESIOLOGIST - WHILE ATTEMPTING TO GAIN LARGE BORE VENOUS ACCESS IN THE RIGHT ANTERIOR CHAMBER SPACE USING A MICROPUNCTURE V ACCESS KIT, THE RIGID NEEDLE WAS IN A VEIN. WHEN THREADING THE GUIDE WIRE INTO THE VEIN, THERE WAS RESISTANCE. AS THE WIRE WAS PULLED, IT LOOKED AS IF IT WAS SHEARING. THE ENTIRE ASSEMBLY-WIRE PLUS NEEDLE OUT TOGETHER. DR AND ANESTHESIA TECH DISCUSSED THE INCIDENT AND INVOLVED VASCULAR SERVICES. VASCULAR SERVICES ADVISED TO CONTINUE ON WITH SURGERY. BEFORE CASE WAS COMPLETED, VASCULAR SURGEON CAME TO VIEW FLUOROSCOPIC IMAGES TO CONFIRM THERE WERE NO FRAGMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774035 ↗
• MalfunctionApr 25, 2019Material Separation; Material Separation

  INFORMATION RECEIVED VIA AN HHS/FDA FORM 3500A MANDATORY EVENT REPORT, (B)(4), REPORTING A (B)(6) YEAR OLD FEMALE WEIGHING (B)(6) KILOGRAMS (KG) WAS UNDERGOING AN ABDOMINAL WASHOUT AND WOUND VACUUMCHANGE, TRACHEOSTOMY PROCEDURE USING A MICROPUNCTURE TRANSITIONLESS ACCESS SET. DURING THE PROCEDURE THE WIRE FROM THE SET WAS SHREDDED UPON REMOVAL FROM THE MICROPUNCTURE INTRODUCER. THE ENTIRE WIRE WAS REMOVED. NO PATIENT ADVERSE EFFECT HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING ADDITIONAL EVENT DETAILS AND PATIENT OUTCOME BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549293 ↗
• MalfunctionMar 14, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING RIGHT FEMORAL ACCESS, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET WIRE GUIDE WAS INSERTED INTO THE SET NEEDLE AND RESISTANCE WAS FELT DURING ADVANCEMENT THROUGH THE NEEDLE. THE WIRE GUIDE THEN BEGAN TO SEPARATE UPON REMOVAL THROUGH THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.  ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7339301 ↗
• MalfunctionJul 28, 2017Split

  WHILE ATTEMPTING TO INSERT THE DILATOR AFTER THE NEEDLE, THE TIP OF THE DILATOR SPLIT. A NEW MICRO-PUNCTURE SET WAS USED TO COMPLETE THE PROCEDURE. NO PARTS OF THE DEVICE REMAINED INSIDE OF THE PATIENTS BODY. NO ADVERSE EVENTS OR ADDITIONAL PROCEDURES WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750182 ↗
• MalfunctionJul 27, 2017Break

  DURING A LOWER LEG ANGIOGRAM, ACCESS WAS GAINED WITH THE NEEDLE, BUT THE NITINOL WIRE"DID NOT FEEL RIGHT" AFTER BEING STUCK IN THE NEEDLE. ONCE THE DEVICE WAS REMOVED, IT WAS NOTED THAT THE TIP OF THE WIRE HAD BROKEN, BUT WAS STILL ATTACHED TO THE MANDREL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6748141 ↗
• MalfunctionJul 25, 2017Split

  WHILE ATTEMPTING TO INSERT THE DILATOR AFTER THE NEEDLE, THE TIP OF THE DILATOR SPILT. A NEW MICROPUNCTURE KIT USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. NO ADDITIONAL PROCEDURES WERE REQUIRED. NO ADVERSE WERE ASSOCIATED IN THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6739720 ↗
• MalfunctionJul 25, 2017Device Damaged Prior to Use; Out-Of-Box Failure; Material Integrity Problem; Torn Material

  PRIOR TO PATIENT CONTACT FOR A CORONARY ANGIOGRAM, IT WAS OBSERVED THAT THE DILATOR WAS FAULTY UPON OPENING THE MICROPUNCTURE SET, THE TIP WAS NOTED TO BE JAGGED AND TORN. IT WAS FURTHER NOTED THAT THE OUTER CATHETER WAS DAMAGED AND NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6739667 ↗
• MalfunctionJul 24, 2017Unraveled Material

  PRIOR TO PATIENT CONTACT, THE PHYSICIAN RAN HIS HAND ALONG THE WIRE TO ENSURE IT FELT OKAY FOR USE AND IT BEGAN TO UNRAVELED NEAR THE DISTAL END. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6737447 ↗
• MalfunctionJul 24, 2017Unraveled Material

  UPON REMOVING THE WIRE FROM THE PATIENT, IT BEGAN TO UNRAVEL NEAR THE DISTAL END. THE ENTIRE WIRE WAS REMOVED FROM THE PATIENT IN TACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6737327 ↗
• MalfunctionJul 18, 2017Break

  PRIOR TO PATIENT CONTACT FOR A CORONARY ANGIOGRAM, IT WAS OBSERVED THAT THE DILATOR WAS FAULTY UPON OPENING THE MICROPUNCTURE SET. IT WAS FURTHER NOTED THAT THE OUTER CATHETER WAS DAMAGED AND NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722934 ↗
• MalfunctionJul 18, 2017Material Separation; Positioning Problem

  IT WAS REPORTED "WHEN THE PACKAGE WAS OPENED IT WAS NOTED THE WIRE IN THE PLASTIC TUBING WAS OUT OF THE TUBING. ANOTHER DEVICE OF THE SAME PRODUCT WAS USED TO DO PROCEDURE". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DURING INVESTIGATION A VISUAL EXAMINATION DISCOVERED THAT THE DISTAL SOLDER CONNECTION HAS SEPARATED FROM THE COIL AND INNER MANDRIL WIRE, RESULTING IN COIL ELONGATION AT THE PROXIMAL END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722787 ↗
• MalfunctionJul 18, 2017Unsealed Device Packaging; Device Dislodged or Dislocated

  IT WAS REPORTED " WHEN THE PACKAGE WAS OPENED IT WAS NOTED THE WIRE IN THE PLASTIC TUBING WAS OUT OF THE TUBING. USED ANOTHER OF THE SAME TO DO PROCEDURE." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DURING THE INVESTIGATION IT WAS NOTED PER VISUAL EXAMINATION OF THE MANDRIL WIRE, THE DISTAL SOLDER CONNECTION SEPARATED FORM THE COIL AND INNER MANDRIL WIRE, RESULTING IN EXTREME COIL ELONGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6722747 ↗
• InjuryAug 3, 2016Material Separation; Material Separation

  PER THE (B)(4), REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT THE PATIENT WAS UNDERGOING EVAR (ENDOVASCULAR ANEURYSM REPAIR). THE MEDICAL DOCTOR (MD) PLACED THE MICROPUNCTURE CATHETER AND THEN ATTEMPTED TO USE A DEVICE TO CLOSE THE LEFT GROIN. WHEN HE (THE PHYSICIAN) REMOVED THE CATHETER, HE NOTED THAT 2CM OF THE TIP OF THE MICROPUNCTURE CATHETER HAD BROKEN OFF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5842828 ↗
• MalfunctionNov 12, 2014Material Separation

  AS REPORTED TO CUSTOMER RELATIONS: THE MICROPUNCTURE SET PULLED APART WHEN THE PHYSICIAN WAS REMOVING IT FROM THE PT. THE PT WAS NOT HARMED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4289921 ↗