PROWATER AGH146300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04547327056144), received between Nov 8, 2020 and Dec 12, 2023 — classified as 4 injuries, 1 malfunction.

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.

• MalfunctionDec 12, 2023Break; Break

  PROWATER WIRE BECAME STUCK IN DISTAL LEFT MAIN/PROXIMAL LAD. PROWATER WIRE BECAME STUCK IN DISTAL LEFT MAIN/PROXIMAL LAD DURING CORONARY INTERVENTION. THE PHYSICIAN NOTICED THAT THE WIRE WAS BROKEN PRIOR TO ADVANCING ANY BALLOON OR STENT. THE PHYSICIAN WAS ABLE TO USE A BALLOON TO PIN THE WIRE TO THE GUIDE CATHETER AND REMOVE EVERYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315432 ↗
• InjuryDec 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI PROWATER GUIDE WIRE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED AND SEVERELY STENOSED LESION IN THE SEGMENT FROM THE LEFT MAIN TRUNK (LMT) TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PROWATER GUIDE WIRE WAS FOUND STUCK BETWEEN THE DISTAL LMT AND THE PROXIMAL LAD AND DAMAGED. A BALLOON CATHETER WAS USED TO FIX THE PROWATER GUIDE WIRE IN AN UNSPECIFIED GUIDING CATHETER, AND THE DEVICES WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH REESTABLISHED BLOOD FLOW BY STENTING. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299109 ↗
• InjuryMar 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 BECAME SEPARATED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A COMPLEX CALCIFIED AND HIGHLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE LESION WAS BALLOONED, ROTABLADED, AND STENTED. THE PROWATER WAS USED DURING BALLOONING AND STENTING. DISSECTION PLANE DISTAL TO DISTAL STENT; THE DISSECTION WAS CREATED BY THE STENT AS IT SHOWED UP AFTER DEPLOYMENT. THE PHYSICIAN WENT BACK IN WITH THE PROWATER TO TRY TO ADDRESS THAT ISSUE. UPON THE THIRD INSERTION, THE WIRE WAS SHAPED WITH AN EXTRA "J" THE WIRE ENDED UP TRAPPED IN A RV MARGINAL. WHEN TRIED TO REMOVE THE CORSAIR, THE GUIDE WIRE FRAYED AND SEPARATED. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO RETRIEVE THE REMAINING PART OF THE GUIDE WIRE, HOWEVER, COULD NOT RETRIEVE IT. BECAUSE BLOOD FLOW IN THE DISTAL RCA WAS BLOCKED, THE PATIENT WAS SENT TO BYPASS SURGERY. THE PATIENT WAS DOING WELL AFTER THE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11490119 ↗
• InjuryMar 12, 2021Material Frayed; Material Separation; Material Deformation

  COMPLEX CALCIFIED LESION. BALLOONED, ROTABLADE, STENT. PROWATER USED DURING BALLOONING AND STENTING. DISECTION PLANE DISTAL TO DISTAL STENT. UPON THE THIRD INSERTION, THE WIRE WAS SHAPED WITH AN EXTRA 'J" THE WIRE ENDED UP TRAPPED IN AN RV MARGINAL. TRIED TO REMOVE WITH CORSAIR. WIRE FRAYED AND SEPERATED. TRIED SNARE. PATIENT SENT TO OR. PATIENT DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11478059 ↗
• InjuryNov 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI PROWATER GUIDE WIRE BROKE OFF DURING A PCI TO TREAT A MODERATELY TORTUOUS LESION IN THE PROXIMAL RCA. THE GUIDE WIRE WAS ADVANCED TO THE LESION IN ATTEMPTS TO CROSS INTO THE PROXIMAL RCA STENT WITH ASSIST OF A NON-ASAHI GUIDELINER. WHEN THE PHYSICIAN ATTEMPTED TO PROLAPSE THE GUIDE WIRE, IT BECAME LODGED AND WHEN ATTEMPTING TO PULL BACK ITS TIP BECAME DISLODGED, AND FREE FROM ITS BODY. THE SEPARATED TIP OF THE GUIDE WIRE WAS UNSUCCESSFULLY RETRIEVED AND LEFT IN THE PATIENT. ANY ADVERSE EFFECTS ON THE PATIENT ASSOCIATED WITH THIS EVENT WERE NOT REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10806532 ↗