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

Model Number 3852

Device Problems Material Rupture (1546); Use of Device Problem (1670)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that balloon ruptured occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left main coronary artery.A 15mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, a balloon pinhole ruptured upon first inflation at 4 atmospheres.The device was removed without any problem and the procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.

Manufacturer Narrative

Correction of b3 - date of event: from 10/20/2023 to 10/19/2023.Correction of h6 - device codes: from use of device problem, a23 to blank.

Event Description

It was reported that balloon ruptured occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left main coronary artery.A 15mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, a balloon pinhole ruptured upon first inflation at 4 atmospheres.The device was removed without any problem and the procedure was completed with another of the same device.No complications were reported, and the patient was in good condition after the procedure.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18080283
• MDR Text Key: 328488180
• Report Number: 2124215-2023-61884
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0028239007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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