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

Model Number 3851

Device Problem Material Rupture (1546)

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

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

It was reported that the balloon ruptured.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified artery.A 10mm x 4.00mm wolverine coronary cutting balloon and a 4.00mm x 12mm nc emerge balloon catheter were selected for use.During the procedure, it was noted that the wolverine balloon ruptured in a vertical shape in the middle part upon second inflation at 10 atmospheres for 20 seconds.The device was removed without any problem.The nc emerge balloon was also ruptured.The procedure was completed with another of the same device.No patient complications were reported and patient was in good condition after the procedure.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that the balloon ruptured.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified artery.A 10mmx4.00mm wolverine coronary cutting balloon and a 4.00mm x 12mm nc emerge balloon catheter were selected for use.During the procedure, it was noted that the wolverine balloon ruptured in a vertical shape in the middle part upon second inflation at 10 atmospheres for 20 seconds.The device was removed without any problem.The nc emerge balloon was also ruptured.The procedure was completed with another of the same device.No patient complications were reported and patient was in good condition after the procedure.It was further reported that the nc emerge balloon catheter also ruptured upon second inflation at 10 atmospheres for 20 seconds.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15914681
• MDR Text Key: 307100469
• Report Number: 2124215-2022-49731
• 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: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029600188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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