PROWATER AGH146000Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04547327056120), received between Sep 29, 2016 and Jul 21, 2026 — classified as 19 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Material Separation

  IT WAS REPORTED THAT AN ASAHI PROWATER GUIDE WIRE WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS 75% OR LESS STENOSIS IN THE RAMUS INTERMEDIUS (RI). THE PROWATER GUIDE WIRE FORMED A LOOP AT THE PROXIMAL RI. AN ATTEMPT WAS MADE TO STRAIGHTEN THE LOOP BY PULLING THE GUIDE WIRE. THE TIP OF THE PROWATER GUIDE WIRE WAS DETACHED AND REMAINED IN THE ARTERY. A STENT WAS DEPLOYED TO EMBED THE FRAGMENT AGAINST THE VESSEL WALL. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED. MFR REPORT #: 3003775027-2026-00140.

  Patient problems: Foreign Body In Patient

  MAUDE report 25895619 ↗
• InjuryJul 16, 2026Material Separation

  IT WAS REPORTED THAT AN ASAHI PROWATER GUIDE WIRE WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS 75% OR LESS STENOSIS IN THE RAMUS INTERMEDIUS (RI). THE PROWATER GUIDE WIRE FORMED A LOOP AT THE PROXIMAL RI. AN ATTEMPT WAS MADE TO STRAIGHTEN THE LOOP BY PULLING THE GUIDE WIRE. THE TIP OF THE PROWATER GUIDE WIRE WAS DETACHED AND REMAINED IN THE ARTERY. A STENT WAS DEPLOYED TO EMBED THE FRAGMENT AGAINST THE VESSEL WALL. IT WAS INFORMED THAT THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25834932 ↗
• InjuryMay 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  USER FACILITY VOLUNTARY MEDWATCH REPORT (MDR REPORT #: MW5117196) WAS RECEIVED VIA THE US DISTRIBUTOR ON MAY 10, 2023. IT WAS REPORTED THAT THE TIP OF AN ASAHI PROWATER GUIDE WIRE BROKE OFF DURING A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A HEAVILY CALCIFIED 90-99% STENOSIS IN THE OSTIUM OF THE RAMUS ARTERY ARISING FROM THE LEFT MAIN (LM). DURING THE PROCEDURE, THE PROWATER WIRE WAS USED IN AN ATTEMPT TO PLACE A DRUG ELUTING STENT. WHEN THE PROWATER WIRE WAS PROTRACTED, IT WAS NOTED TO HAVE COME BACK AND THE TIP OF THE WIRE WAS SEEN EMBOLIZED TO THE DISTAL RAMUS. THE STENT REMAINED PARTIALLY IN THE LM. GIVEN THE NON-OBSTRUCTIVE LM DISEASE, FURTHER MANEUVERS WERE FELT TO BE UNSAFE. THE DECISION WAS MADE TO LEAVE THE RAMUS AS A PTCA ALONE. GIVEN THE WIRE FRAGMENT WAS VERY DISTAL, ATTEMPTS TO SNARE THE FRAGMENT WERE FELT TO BE HIGH RISK FOR CAUSING ISCHEMIA AND VESSEL INJURY. IT IS ESTIMATED THAT THE RETAINED FRAGMENT MEASURES APPROXIMATELY 2.5 CM. NO IDENTIFIED ADVERSE OUTCOMES TO DATE. PATIENT DISCHARGED TO HOME WITHOUT HARM RELATED TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16971106 ↗
• MalfunctionMay 16, 2023Fracture; Fracture

  TYPE OF PROCEDURE-OTHER DEVICES USED-LESION INFORMATION - DIAGNOSTIC CATH -LHB W/WO LV, IVUS SINGLE VESSEL, INTERVENTIONAL CATHETERIZATION - SINGLE DE STENT, CATH ADJ DX - PERIPHERAL IVUS ADDL VESSEL. LEVEL OF DISEASE-CALCIUM ETC[?].. LESION IN TRUE RAMUS ARISING FROM THE LM. 99% STENOSIS IN OSTIAL RI WITH TIMI2 FLOW CONCERNING FOR PLAQUE RUPTURE. PATIENT HARM - NO HARM DETECTED. DEVICE ABLE TO BE RETURNED? NO. MDR REPORT #: MW5117196 [INITIAL REPORTER: (B)(6) (NURSE)]. [DESCRIBE EVENT OR PROBLEM]. DURING INTERVENTIONAL CARDIAC PROCEDURE, PROWATER WIRE USED IN AN ATTEMPT TO PLACE STENT. WHEN THE PROWATER WIRE WAS PROTRACTED, IT WAS NOTED TO HAVE COME BACK AND THE TIP OF THE WIRE WAS SEEN EMBOLIZED TO THE DISTAL RAMUS. THE STENT REMAINED PARTIALLY IN THE LM. GIVEN THE NONOBSTRUCTIVE LM DISEASE, FURTHER MANEUVERS WERE FELT TO BE UNSAFE. THE DECISION WAS MADE TO LEAVE THE RI AS A PTCA ALONE. GIVEN THE WIRE FRAGMENT WAS VERY DISTAL, ATTEMPTS TO SNARE THE FRAGMENT WERE FELT TO BE HIGH RISK FOR CAUSING ISCHEMIA AND VESSEL INJURY. IT IS ESTIMATED THAT THE RETAINED FRAGMENT MEASURES APPROXIMATELY 2.5 CM. NO IDENTIFIED ADVERSE OUTCOMES TO DATE. PATIENT DISCHARGED TO HOME ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 16942839 ↗
• MalfunctionMay 16, 2023Material Integrity Problem; Material Integrity Problem

  CROSSED THROUGH A DOUBLE-JAILED SIDE BRANCH WITH INTENT OF PROTECTING IT PRIOR TO POST-DILATION. THE RADIO-OPAQUE PORTION PASSED INTO THE SIDE BRANCH BUT I COULD NOT ADVANCE IT FURTHER. I THEN TRIED TO RETRACT THE WIRE (THIS IS ALL PRIOR TO ANY POST-DILATION/BALLOONING OF THE DOUBLE-JAILED AREA) AND IT WOULD NOT RETRACT. I TRIED TO FREE IT UP BY PASSING A 2.0 BALLOON OVER IT AND IT WOULD NOT. THEN WITH GENTLE PRESSURE I FELT THE WIRE GIVE. WITH FURTHER PRESSURE I WAS ABLE TO RETRIEVE THE WHOLE WIRE INCLUDING THE RADIO-OPAQUE TIP. AFTER REMOVING IT FROM THE BODY IT WAS CLEAR IT HAD UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16940765 ↗
• MalfunctionMay 1, 2023Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO TREAT AN UNSPECIFIED LESION IN THE CORONARY ARTERY. AN ASAHI PROWATER GUIDE WIRE WAS USED TO CROSS THROUGH A DOUBLE-JAILED SIDE BRANCH WITH INTENT OF PROTECTING IT PRIOR TO POST-DILATION. THE RADIOPAQUE PORTION PASSED INTO THE SIDE BRANCH BUT IT COULD NOT ADVANCE FURTHER. THE OPERATOR THEN TRIED TO RETRACT THE WIRE (THIS WAS ALL PRIOR TO ANY POST-DILATION/BALLOONING OF THE DOUBLE-JAILED AREA) AND IT WOULD NOT RETRACT. THE OPERATOR TRIED TO FREE IT UP BY PASSING A 2.0 BALLOON OVER IT AND IT WOULD NOT. THEN WITH GENTLE PRESSURE THE OPERATOR FELT THE WIRE GIVE. WITH FURTHER PRESSURE IT WAS ABLE TO RETRIEVE THE WHOLE WIRE INCLUDING THE RADIOPAQUE TIP. AFTER REMOVING IT FROM THE PATIENT BODY, IT WAS CLEAR IT HAD UNRAVELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16850693 ↗
• InjuryMar 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI PROWATER (RINATO) GUIDE WIRE BROKE OFF DURING PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A 90% STENOSIS IN THE CORONARY ARTERY. BEFORE BALLOONING, INTRAVASCULAR ULTRASOUND (IVUS) WAS DONE TO ASSESS PRIOR TO STENTING AND IT WAS NOTED THE DISTAL EDGE OF PROWATER GUIDE WIRE HAD DISLODGED INTO A SMALL VESSEL AT THE VERY DISTAL PART OF THE HIGH OBTUSE MARGINAL BRANCH (OM1).THE PHYSICIAN ATTEMPTED TO SNARE IT BUT IT WENT UNSUCCESSFUL. AFTER CONSULTING WITH SURGEON AND PEERS, DECISION WAS MADE NOT TO PROCEED WITH ANY INTERVENTION TO REMOVE THE WIRE EITHER ENDOVASCULARLY OR SURGICALLY. THE WIRE FRAGMENT WAS LEFT IN THE PATIENT. THE PATIENT DID WELL WITHOUT ADVERSE EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16542721 ↗
• InjuryMar 13, 2023Material Fragmentation; Material Fragmentation

  DURING HEART CATH ON (B)(6) 2023 BALLOON ANGIOPLASTY WAS DONE WITH LESION OPENING UP. INTRAVASCULAR ULTRASOUND WAS DONE TO ASSESS PRIOR STENT AND IT WAS NOTED DISTAL EDGE OF PROWATER WIRE HAD DISLODGED INTO A SMALL VESSEL AT THE VERY DISTAL PART OF THE HIGH OML. ATTEMPTED TO SNARE IT UNSUCCESSFUL. CONSULTED WITH SURGEON AND PEERS AND DECISION MADE TO NOT PROCEED WITH ANY INTERVENTION TO REMOVE THE WIRE EITHER ENDOVASCULARLY OR SURGICALLY. FOREIGN BODY LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16534899 ↗
• MalfunctionJun 12, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT "PATIENT WAS ADMITTED TO HOSPITAL AS A CODE BLUE STEMI AND CATH LAB TREATED THIS 68 YEAR OLD MALE PATIENT WITH OCCLUDED DISTAL CIRCUMFLEX ARTERY WITH MILD CALCIFICATION AND LESION TORTUOSITY, PROWATER WAS DELIVERED WITHOUT THE USE OF ADDITIONAL SUPPORT AND MANIPULATED INTO THE DISTAL CIRCUMFLEX, BSC 2.5 CM BALLOON WAS DELIVERED OVER GUIDE WIRE AND PROWATER WAS THEN IDENTIFIED AS HAVING SEPARATED AT THE TIP." NO ADDITIONAL DETAILS ARE AVAILABLE. WIRE AND BALLOON WERE REMOVED WITHOUT INCIDENT AND THE CASE WAS COMPETED WITH ANOTHER PROWATER 190 WIRE WITH SAME LOT #. PATIENT WAS STABILIZED AND RECOVERED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672618 ↗
• MalfunctionJun 7, 2022Material Separation

  PATIENT WAS ADMITTED TO HOSPITAL AS A CODE BLUE STEMI AND CATH LAB TREATED THIS 68 YEAR OLD MALE PATIENT WITH OCCLUDED DISTAL CIRCUMFLEX ARTERY, PROWATER WAS DELIVERED WITHOUT THE USE OF ADDITIONAL SUPPORT AND MANIPULATED INTO THE DISTAL CIRC, BSC 2.5 CM BALLOON WAS DELIVERED OVER GUIDE WIRE AND PROWATER WAS THEN IDENTIFIED AS HAVING SEPARATED AT THE TIP" NO ADDITIONAL DETAILS ARE AVAILABLE. WIRE AND BALLOON WERE REMOVED WITHOUT INCIDENT AND THE CASE WAS COMPETED WITH ANOTHER PROWATER 190 WIRE WITH SAME LOT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14627300 ↗
• InjuryNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM THE USER FACILITY VIA MAIL THAT AS ASAHI PROWATER GUIDE WIRE WAS USED IN THE PATIENT IN CATH LAB FOR STENTING OF SEVERELY CALCIFIED CORONARY ARTERY. THE WIRE BECAME LODGED IN THE CORONARY VESSEL POST STENTING. THE WIRE FRACTURED AND BROKE INSIDE THE VESSEL. ATTEMPTS WERE MADE TO RETRIEVE, HOWEVER, THE FRAGMENT MIGRATED INTO THE AORTA. THE PATIENT WAS TRANSFERRED TO A TERTIARY CARE CENTER. A 10 CM SEGMENT WAS REMOVED DURING SURGERY AT A DIFFERENT HOSPITAL. THE RETRIEVED FRAGMENT WAS DISCARDED. THE PATIENT WAS RELEASED AFTER SEVERAL DAYS POST OP. THE USER FACILITY HAD A ROOT CAUSE ANALYSIS POST EPISODE WITH THIS CONCLUSION: "NOT OPERATOR OR EQUIPMENT AT FAULT".

  Patient problems: Insufficient Information

  MAUDE report 12784168 ↗
• InjuryOct 20, 2021Break; Fracture; Migration or Expulsion of Device

  PATIENT IN CATH LAB FOR STENTING OF CORONARY ARTERY. WIRE BECAME LODGED IN CORONARY VESSEL POST STENT. WIRE FRACTURED AND BROKE INSIDE VESSEL. ATTEMPT MADE TO RETRIEVE, MIGRATED INTO AORTA. TRANSFERRED TO TERTIARY CARE CENTER

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12669388 ↗
• InjurySep 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI PROWATER GUIDE WIRE HAD SEPARATED AND REMAINED IN THE PATIENT DURING BALLOON ANGIOPLASTY TO TREAT AN UNSPECIFIED LESION IN THE RIGHT CORONARY ARTERY (RCA). THE WIRE WAS INSERTED IN THE RCA. AN UNSPECIFIED BALLOON WAS THEN ADVANCED OVER THE GUIDE WIRE, INFLATED, AND DEFLATED. WHEN THE BALLOON WAS BEING REMOVED, THE PHYSICIAN FELT RESISTANCE AND ADDED EXTRA PRESSURE TO PULL IT BACK. IT WAS NOTICED THAT THE WIRE WAS FRACTURED, AND THE DISTAL END OF WIRE WAS LEFT IN THE RCA. THE WIRE FRAGMENT WAS NOT MOVED AND AN ATTEMPT TO RETRIEVE IT WAS NOT MADE DUE TO CONTRAST AMOUNT. THE PATIENT WAS BROUGHT BACK TWO DAYS LATER. THE LESION WAS STENTED WITH THE WIRE FRAGMENT IN THE RCA TO THE ARTERIAL WALL WITH SUCCESS. THE PROCEDURE WAS SUCCESSFUL AND PATIENT IS DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12485720 ↗
• MalfunctionSep 13, 2021Fracture

  INITIAL INFORMATION REPORTED FROM HOSPITAL AS I WAS NOT IN CASE. PROWATER WAS INSERTED IN RCA, BALLOON WAS ADVANCED OVER PROWATER, BALLOON WAS INFLATED, DEFLATED, AND WHEN BALLOON WAS BEING REMOVED THE PHYSICIAN NOTICE WIRE WAS FRACTURED, AND THE DISTAL END OF WIRE WAS LEFT IN RCA. THIS WAS NOT REMOVED AND PLANS FROM NOTES WERE THE PHYSICIAN WOULD BRING PATIENT BACK SEVERAL DAYS LATER FOR STENTING LOOSE WIRE TO ARTERIAL WIRE.

  Patient problems: Insufficient Information

  MAUDE report 12465565 ↗
• InjuryJul 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI PROWATER GUIDE WIRE HAD SEPARATED DURING A PROCEDURE TO TREAT A 99% STENOSIS IN THE NON-TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE, THE PROWATER GUIDE WIRE AND A BOSTON SCIENTIFIC CHOICE PT EXTRA SUPPORT GUIDE WIRE WERE INSERTED TO THE TARGET ARTERY. WHEN TRYING TO REMOVE THE WIRES, THE PROWATER GOT STUCK WITHIN THE LAD WITH UNCLEAR CAUSE. THE PHYSICIAN ATTEMPTED TO MANIPULATE THE GUIDE CATHETER FOR ADDED SUPPORT, AS WELL AS ATTEMPTED TO INSERT A COMPLIANT 2.0MM X 15MM BALLOON FOR ADDED SUPPORT, AND STILL COULD NOT DISLODGE THE WIRE. THE CHOICE PT EXTRA SUPPORT GUIDE WIRE WAS REMOVED, THE PROWATER AND COMPLIANT BALLOON REMAINED. WITH ANOTHER ATTEMPT TO REMOVE THE WIRE (AND NOW BALLOON), THE PHYSICIAN WAS ABLE TO PULL BOTH BACK. HOWEVER, IT WAS NOTED THAT THE TIP OF THE PROWATER STILL REMAINED IN THE CORONARY VASCULATURE. ANGIO IMAGES REVEALED THAT THE WIRE FRAGMENT WAS LOCATED IN A SMALL VESSEL WITHIN THE AV GROOVE OF THE LEFT CIRCUMFLEX ARTERY. THE DECISION BY THE PHYSICIAN WAS TO LEAVE THE WIRE FRAGMENT IN SITU AS THE FRAGMENT WAS SMALL AND LOCATED IN A SMALL VESSEL, WHICH MAY HAVE NO IMPACT ON THE HEMODY

  Patient problems: Foreign Body In Patient

  MAUDE report 12194158 ↗
• InjuryJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI PROWATER GUIDE WIRE DISLODGED AND REMAINED IN VASCULATURE DURING A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A CHRONIC TOTAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE GUIDE WIRE WAS USED IN ATTEMPTS TO CROSS THE CTO WHEN ITS TIP WAS LODGED IN THE LESION AND CAME UNRAVELED AT THE TIP. A TULIP SNARE WAS USED TO RETRIEVE THE TIP BUT THE ATTEMPT WAS ENDED UNSUCCESSFULLY. A STENT WAS PLACED TO COMPRESS THE TIP AGAINST THE VESSEL WALL TO KEEP IT FROM MOVING DISTALLY. THERE WAS NO COMPLICATION WITH THE PATIENT OR PROCEDURE ASSOCIATED WITH THIS EVENT. ON AUGUST 2, ADDITIONAL INFORMATION WAS OBTAINED: THE USER FACILITY CONFIRMED THAT THERE WAS NO OTHER IMPACTED WIRE FOR THIS CASE OTHER THAN THE RETURNED GUIDE WIRE WHICH WAS NON-ASAHI PRODUCT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12171656 ↗
• MalfunctionJul 6, 2021Break

  TRIED TO CROSS MID LAD CTO WITH PROWATER TIP BROKE OFF TRIED TO RETRIEVE WITH RETRIEVABLE DEVICE END UP STENTING OVER THE TIP PORTION TO KEEP IN PLACE. NO COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 12122687 ↗
• InjuryJul 2, 2021Material Fragmentation; Device Dislodged or Dislocated

  PER MD REPORT WHEN REMOVING GUIDEWIRE A SMALL FRAGMENT BROKE FROM THE DISTAL EDGE OF THE GUIDWIRE AND DISLOGDED INTO CORONARY VASCULATURE, WENT INTO A VERY SMALL VESSEL WITHIN THE DISTAL LEFT CIRCUMFLEX ARTERY. ANGIOGRAPHICALLY NO FLOW COMPROMISE RELATED TO SMALL WIRE FRAGMENT. LAD RESULT VERY GOOD. RESIDUAL STENOSIS 0%.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12110285 ↗
• InjuryJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI PROWATER GUIDE WIRE HAD SEPARATED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A 90% STENOSIS WITH MILD TORTUOSITY AND MODERATE CALCIUM LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TIP OF THE PROWATER BROKE OFF AFTER IT WAS INSERTED AND ATTEMPTED TO CROSS THE LESION. CALCIUM WAS MODERATE AND MILD TORTUOSITY. THE WIRE FRAGMENTED ON THE FIRST CROSSING ATTEMPT. MILD PUSH FORCES AND MODERATE TORQUE WAS BEING APPLIED AT THE TIME. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE TIP FROM THE VESSEL BY USING A SNARE. AFTER FRAGMENT REMOVAL, THE PROCEDURE THEN WAS COMPLETED AS NORMAL. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. TWO PROWATER GUIDE WIRES WERE USED IN THE CASE: PROWATER 1 WAS FROM LOT 201223A06A AND PROWATER 2 WAS FROM LOT 201126A33A; HOWEVER, THE LOT BELONGING TO THE AFFECTED DEVICE WAS NOT KNOWN. THE LOT NUMBER, EXPIRATION DATE, UDI, DEVICE MANUFACTURER DATE FOR PROWATER 2 ARE IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055946 ↗
• MalfunctionJun 16, 2021Unraveled Material

  INTERVENTIONAL WIRE SLIGHTLY UNRAVELED. THUS, THE DEVICE MALFUNCTION AND DID NOT DO WHAT IT WAS SUPPOSED TO.

  Patient problems: Insufficient Information

  MAUDE report 12006345 ↗
• MalfunctionJun 4, 2021Break

  PROWATER CAME APART WHILE INSIDE PATIENTS LAD. FROM HOSPITAL PERSONNEL, "PLEASE ADVISE PROCESS TO HAVE ASAHI PROWATER 180CM ANALYZED AS IT SHEARED AND BROKE APART INSIDE A PATIENT'S CORONARY ARTERY." TWO PROWATERS WERE USED IN THE CASE, THEY ARE NOT SURE WHICH LOT NUMBER THE PROWATER THAT CAME APART IS SO /I HAVE SUBMITTED REPORTS FOR BOTH.

  Patient problems: Foreign Body In Patient

  MAUDE report 11943072 ↗
• MalfunctionJun 4, 2021Break; Entrapment of Device; Detachment of Device or Device Component

  PROWATER CAME APART INSIDE PATIENTS LAD. FROM THE HOSPITAL PERSONNEL, "PLEASE ADVISE PROCESS TO HAVE ASAHI PROWATER 180CM ANALYZED AS IT SHEARED AND BROKE APART INSIDE A PATIENT'S CORONARY ARTERY."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11942557 ↗
• MalfunctionNov 9, 2020Material Separation

  WHEN WIRE WAS ENTERED INTO THE BODY THE PHYSICIAN NOTICED THE SEPARATION OF THE WIRE. REMOVED AND INSERTED SECOND WIRE. SAME SEPARATION. REMOVED AND USED DIFFERENT WIRE. NOTHING LEFT IN BODY.

  Patient problems: Insufficient Information

  MAUDE report 10814431 ↗
• MalfunctionNov 19, 2019Unraveled Material

  THE WIRE WAS OPENED AND PREPPED. PLACED INTO THE BODY AND THE PHYSICIAN NOTICED THE WIRE DIDN'T LOOK PROPER ON THE INITIAL ANGIOGRAPHY. THE WIRE NEVER ENGAGED THE CORONARY ARTERIES AND WAS REMOVED. UPON REMOVAL THE WIRE WAS INSPECTED AND NOTICED THAT THE MID-PORTION OF THE WIRE APPEARS TO HAVE COME UNRAVELED. THERE WAS NO ADVERSE EVENT. A NEW WIRE WAS OPENED AND THE CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9344885 ↗
• InjurySep 23, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION IN THE LEFT MAIN OR LEFT ANTERIOR DESCENDING ARTERY. AN ASAHI PROWATER GUIDE WIRE WAS USED AND ITS COATING WAS FOUND COME OFF DURING USAGE IN THE PATIENT. THE GUIDE WIRE WAS SIMPLY TAKEN OUT AND REPLACED WITH A NEW GUIDE WIRE TO PRESUME THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9107727 ↗