CONFIANZA PRO 12 AGH143391Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547327058162), received between Jul 20, 2017 and Oct 24, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  USER FACILITY VOLUNTARY MEDWATCH REPORT (MDR REPORT #: MW5145569) WAS RECEIVED VIA THE US DISTRIBUTOR ON SEPTEMBER 27, 2023. IT WAS REPORTED THAT A LEGALLY BLIND AND WHEELCHAIR-BOUND PATIENT WHO HAD A HISTORY OF DIABETES MELLITUS, HYPERTENSION, AND PERIPHERAL ARTERY DISEASE UNDERWENT ANGIOGRAPHY AND PERCUTANEOUS PERIPHERAL INTERVENTION (PPI). ANGIOGRAM REVEALED SEVERE STENOSIS IN THE LEFT POPLITEAL ARTERY. ALL OF THE THREE TIBIAL VESSELS WERE OCCLUDED ON THE LEFT POSTERIOR TIBIAL ARTERY. THE PROXIMAL LEFT ANTERIOR TIBIAL ARTERY WAS PATENT, WHILE OCCLUSION WAS OBSERVED IN THE PROXIMAL POUCH. IN SPITE OF ATTEMPTS TO CROSS THE ANTERIOR TIBIAL ARTERY WITH AN ASAHI CONFIANZA PRO 12 GUIDE WIRE, IT COULD BE ADVANCED AS FAR AS THE DISTAL SEGMENT OF THE LESION. AT THIS POINT, THE PHYSICIAN DETERMINED TO PRESERVE THE POSTERIOR TIBIAL ARTERY FOR FUTURE USE AS A BYPASS GRAFT. AN UNSPECIFIED 3MM X 120MM BALLOON WAS DILATED FOR INSUFFICIENT 2 MINUTES OR MORE TO PERFORM BALLOON ANGIOPLASTY TO THE PROXIMAL SEGMENT OF THE ANTERIOR TIBIAL ARTERY AND THE OVERALL POPLITEAL ARTERY, WHICH IMPROVED THE BLOOD FLOW IN THE TIBIAL ARTERY. THE DISTAL SEGMENT OF THE CONFIANZA PRO 12 WAS FOUND FRACTURED AND LEF

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18000163 ↗
• InjuryAug 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CONFIANZA PRO 12 GUIDE WIRE DETACHED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION TO TREAT A STENOSIS IN LEFT COMMON ILIAC ARTERY (CIA), OCCLUSION IN THE RIGHT CIA, AND CHRONIC TOTAL OCCLUSIONS (CTO) IN THE LEFT AND RIGHT SUPERFICIAL FEMORAL ARTERIES (SFA). THE EVENT DESCRIPTION WAS PROVIDED AS BELOW: OPERATIONS PERFORMED: 1. U/S-GUIDED BILATERAL CFA ACCESS, 2. BILATERAL ILIAC ARTERY PRESSURE MEASUREMENTS, 3. BILATERAL COMMON ILIAC ARTERY (CIA) ANGIOPLASTY, 4. RIGHT CIA STENTING (7 X 59 VBX BES), 5. LEFT SFA RECANALIZATION, 6. LEFT SFA ANGIOPLASTY AND STENTING (5 X 120 ABBOTT SUPERA STENTS X 2; OVERLAPPING IN THE SFA), 7. ATTEMPTED RECANALIZATION OF RLE SFA (UNSUCCESSFUL), 8. BILATERAL PROGLIDE PERCLOSE ACCESS CLOSURE (1 DEVICE PER SIDE). IMPLANTED DEVICES: 1. GORE VBX 7 MM X 59 MM BALLOON EXPANDABLE STENT IN THE RIGHT CIA. 2. ABBOTT SUPERA 5 MM X 120 MM SELF-EXPANDABLE STENTS X 2 IN THE LEFT SFA. DESCRIPTION: BILATERAL FEMORAL ACCESS PERFORMED TO ALLOW FOR AORTIC AND ILIAC PRESSURE MEASUREMENTS AND TREATMENT. PROCEEDED THEN WITH CONTRALATERAL 7F SHEATH ACCESS, STARTING WITH TREATING THE LEFT LEG FIRST. ANGIOPLASTY OF LEFT SFA WITH 5 MM X 2

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15171160 ↗
• MalfunctionAug 3, 2022Break; Entrapment of Device

  OPERATIONS PERFORMED: 1. U/S-GUIDED BILATERAL CFA ACCESS. 2. BILATERAL ILIAC ARTERY PRESSURE MEASUREMENTS. 3. BILATERAL COMMON ILIAC ARTERY (CIA) ANGIOPLASTY. 4. RIGHT CIA STENTING (7 X 59 VBX BES). 5. LEFT SFA RECANALIZATION. 6. LEFT SFA ANGIOPLASTY AND STENTING (5 X 120 ABBOTT SUPERA STENTS X 2; OVERLAPPING IN THE SFA). 7. ATTEMPTED RECANALIZATION OF RLE SFA (UNSUCCESSFUL). 8. BILATERAL PROGLIDE PERCLOSE ACCESS CLOSURE (1 DEVICE PER SIDE). IMPLANTED DEVICES: 1.  GORE VBX 7 MM X 59 MM BALLOON EXPANDABLE STENT IN THE RIGHT CIA. 2. ABBOTT SUPERA 5 MM X 120 MM SELF-EXPANDABLE STENTS X 2 IN THE LEFT SFA. DESCRIPTION: BILATERAL FEMORAL ACCESS PERFORMED TO ALLOW FOR AORTIC AND ILIAC PRESSURE MEASUREMENTS AND TREATMENT. PROCEEDED THEN WITH CONTRALATERAL 7F SHEATH ACCESS, STARTING WITH TREATING THE LEFT LEG FIRST. ANGIOPLASTY OF LEFT SFA WITH 5 MM X 200 MM BALLOON AND 6 X 80 MM BALLOONS BEFORE PLACING 5 MM X 120 MM SUPERA STENTS X 2 IN THE LEFT SFA FOR LEFT SFA OCCLUSION. MOVED TO RIGHT SIDE. SIMILAR ACCESS WITH 7F SHEATH FROM THE LEFT SIDE. ATTEMPTED TO CROSS THE R SFA CTO, UNSUCCESSFUL. COMPLICATIONS: TIP OF THE 0.014 WIRE (0.5 CM LONG) REMAINED IN THE PATIENT'S RIGHT SFA OCCLUSION WITH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15158771 ↗
• InjuryAug 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO TREAT A MILDLY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). WHILE ADVANCING AN ASAHI CONFIANZA PRO 12 GUIDE WIRE IN THE SUBINTIMAL PLANE AROUND THE CTO, ABOUT 4MM OF THE WIRE TIP BROKE OFF AND REMAINED IN THE SUBINTIMAL SPACE. THE PHYSICIAN COMMENTED THAT THE GUIDE WIRE WAS NOT PROLAPSED WHEN DAMAGED AND WAS USED AGGRESSIVELY. THE DAMAGED GUIDE WIRE WAS REMOVED FROM THE SUBINTIMAL PLANE WITHOUT RESISTANCE. ANOTHER CONFIANZA PRO 12 GUIDE WIRE WAS USED TO RESUME THE PROCEDURE. AN ASAHI ASTATO 30 GUIDE WIRE WAS USED TO RE-ENTER THE TRUE LUMEN AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH STENT DEPLOYMENT, WHICH WAS PART OF THE TREATMENT PLAN FOR REVASCULARIZATION. THERE WERE NO DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS REPORTEDLY FINE AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12305312 ↗
• InjuryDec 12, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  SUS VOLUNTARY EVENT REPORT (REPORT NUMBER: MW5081406) WAS RECEIVED FROM THE IMPORTER. IT WAS REPORTED AS FOLLOWS: PATIENT UNDERWENT ANGIOGRAPHY OF BOTH LEGS DURING PROCEDURE A SMALL FRAGMENT OF THE CHRONIC TOTAL OCCLUSION WIRE WAS BROKEN IN THE RIGHT SFA. NO APPARENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8158515 ↗
• InjuryJul 20, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE CHRONIC, TOTALLY OCCLUDED POSTERIOR TIBIA VESSEL, THE ASAHI CONFIANZA GUIDE WIRE WAS BEING MANIPULATED WHEN THE TIP BECAME DETACHED IN THE OCCLUSION. THE DEVICE FRAGMENT WAS REMOVED USING A SNARE DEVICE WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6730686 ↗