MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 39345-351510

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery-below the knee.A 3.5mmx15mm wolverine peripheral cutting balloon was selected for use.During procedure, the balloon ruptured upon first inflation at 10 atmospheres within 30 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications reported and the patient was in good condition after the procedure.

Manufacturer Narrative

H6 -device codes: corrected.A wolverine pcb event was submitted to capture the event of "balloon was ruptured".However, as per additional information received on 31jul2023, "(b)(4) is a duplicate report of (b)(4).Please cancel this complaint record".Therefore, only one complaint will remain open to capture the problem and the other complaint (b)(4) will be closed as 'duplicate'.Any relevant information regarding the reported event will be captured by the complaint under (b)(4).

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified popliteal artery-below the knee.A 3.5mmx15mm wolverine peripheral cutting balloon was selected for use.During procedure, the balloon ruptured upon first inflation at 10 atmospheres within 30 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications reported and the patient was in good condition after the procedure.

• Brand Name: WOLVERINE PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 15729871
• MDR Text Key: 307070544
• Report Number: 2124215-2022-43570
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-351510
• Device Catalogue Number: 39345-351510
• Device Lot Number: 0029680201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1