PROWATER AGH146000JRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327056182), received between Feb 18, 2020 and Apr 27, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 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 MODERATELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE MID TO DISTAL RIGHT CORONARY ARTERY (RCA). ANTEGRADE WIRE ESCALATION WAS PERFORMED WITH A CORSAIR PRO MICROCATHETER. A PROWATER WAS USED TO THE CTO CAP, THEN ESCALATED WITH FIELDER XT, GLADIUS MONGO, AND GAIA GUIDE WIRE TO SUCCESSFULLY CROSS THE LESION. THEN THE GUIDE WIRE WAS SWAPPED BACK TO A WORKHORSE WIRE (PROWATER). THE TIP OF THE PROWATER CAUGHT VERY TINY DISTAL BRANCH AND WAS TRAPPED FOR A SECOND. THE PHYSICIAN RETRACTED THE WIRE AND THE WIRE BEGAN TO UNRAVEL. THE PHYSICIAN WAS ABLE TO REMOVE TRAP OF THE WIRE WITH A MICROCATHETER. INTRAVASCULAR ULTRASOUND (IVUS) AND OPTICAL COHERENCE TOMOGRAPHY (OCT) CONFIRMED THAT THERE WAS NO A WIRE FRAGMENT IN THE MAIN VESSEL. ONLY SMALL AMOUNT OF A WIRE FRAGMENT IN TINY BRANCH WAS VISUAL BY ANGIOGRAPHY. OCT CONFIRMED MAIN RCA AND PDA WERE FINE AND THE PHYSICIAN FINISHED THE CASE BY STENTING OVER A NEW PROWATER WIRE. THE PATIENT WAS FINE AND THE PCI WAS SUCCESSFULLY OPEN THE CTO.

  Patient problems: Foreign Body In Patient

  MAUDE report 11735533 ↗
• MalfunctionApr 15, 2021Material Fragmentation

  CTO OF RCA MID TO DISTAL. AFTER AWE WITH CORSAIR PRO (PROWATER TO CAP, FIELDER XT, MONGO, GAIA, CROSSED LESION) SWAPPED BACK TO WORKHORSE WIRE (PROWATER). TIP OF PROWATER CAUGHT VERY TINY DISTAL BRANCH AND WAS TRAPPER FOR A SECOND. PHYSICIAN RETRACTED WIRE AND THE WIRE BEGAN TO UNRAVEL. PHYSICIAN WAS ABLE TO REMOVE TRAP MOST OF THE FRAGMENT WITH MICROCATHETER AND REMOVE WIRE AND SOME WIRE GRAGMENT. CONFIRMED WITH INVUS AND OCT THAT THERE WAS NOT A WIRE FRAGMENT IN MAIN VESSEL, ONLY SMALL AMOUNT IN TINY BRANCH VISUAL BY ANGIOGRAPHY. OCT CONFIRMED MAIN RCA/PDA WERE FIND AND WE FINISHED THE CASE BY STENTING OVER NEW PROWATER WIRE. PATIENT WAS FINE. CTO OPENED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11675292 ↗
• MalfunctionApr 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VASOSPASM DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE RIGHT CORONARY ARTERY (RCA), CAUSING A MYOCARDIAL INFARCTION (MI). AN ASAHI PROWATER GUIDE WIRE BECAME TRAPPED WHEN THE VESSEL SPASMED, DIFFICULTY WAS NOTED WHEN ATTEMPTING TO REMOVE THE WIRE FROM THE SPASMED VESSEL, AND UPON REMOVAL IT WAS NOTED THAT THE DISTAL PORTION OF THE WIRE (SPRING COIL) BECAME ELONGATED. THE PATIENT SUFFERED A MI DURING THE PROCEDURE BUT SURVIVED AND IS STABLE AND DISCHARGED AFTER TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11662824 ↗
• MalfunctionMar 25, 2021Entrapment of Device; Material Deformation

  PATIENT EXPERIENCED VASOSPASM DURING PCI OF RCA CAUSING A MYOCARDIAL INFARCTION. THE PROWATER WIRE BECAME TRAPPED WHEN THE VESSEL SPASMED, DIFFICULTY WAS NOTED WHEN ATTEMPTING TO REMOVE THE WIRE FROM THE SPASMED VESSEL, AND UPON REMOVAL IT WAS NOTED THAT THE DISTAL PORTION OF THE WIRE (SPRING COIL) BECAME ELONGATED. PLEASE REFER TO THE ATTACHED PICTURE OF THE PROWATER WIRE AFTER IT WAS REMOVED FROM THE BODY. PLEASE NOTE THAT THIS INCIDENT OCCURRED ON (B)(6) 2020. I TRIED TO SUBMIT THE INCIDENT AT THAT TIME, BUT WHEN THE PHYSICIAN REACHED OUT TO ME ON (B)(6) 2021 I NOTICED THAT I HAD NO RECORD OF THE INCIDENT REPORT IN MY EMAIL POTENTIALLY DUE TO THE VOLATILITY OF THE EMAIL SERVERS DURING THAT TIME PERIOD. THE PHYSICIAN IS REQUESTING AN ANALYSIS REPORT.

  Patient problems: Myocardial Infarction

  MAUDE report 11569264 ↗
• InjuryFeb 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  SUS VOLUNTARY EVENT REPORT #: MW5092361 WAS RECEIVED ON FEBRUARY 5, 2020. IT WAS REPORTED THAT THE PATIENT A PCI WAS PERFORMED ON THE PATIENT WITH HISTORY OF SEVERE AORTIC STENOSIS AND SINGLE-VESSEL CORONARY ARTERY DISEASE. THE PATIENT HAD TAVR AND PCI OF THE LAD WITH MILD TORTUOSITY AND CALCIFICATION. DURING THE PROCEDURE, THE GUIDE WIRE GOT STUCK IN THE STENT AND A PORTION OF IT WAS RETAINED IN THE PATIENT; 5 DAYS LATER, CABG WAS PERFORMED AND ATTEMPT WAS MADE TO REMOVE RETAINED PORTIONS OF WIRE BUT WAS UNSUCCESSFUL. PORTION OF THE WIRE THAT WAS CUT OFF BY THE STENT WAS REMOVED DURING BYPASS SURGERY. AT THE TIME THE VOLUNTARY REPORT WAS SUBMITTED, THE PATIENT REMAINED IN ICU IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 9724050 ↗