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

Model Number 3850

Device Problem Material Rupture (1546)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery.A 6mm x 2.75mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at 10 atmospheres within 20 seconds.The balloon was removed from the patients body without any problem using the normal method and the procedure was completed with a different device.No complications were reported and the patient was in good condition after the procedure.

Event Description

It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery.A 6mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at 10 atmospheres within 20 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No complications were reported, and the patient was in good condition after the procedure.

Manufacturer Narrative

E1 - initial reporter address: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon wings were in a deflated state and had been subjected to positive pressure.A microscopic examination confirmed longitudinal tear in the balloon material.The tear stretched from 1mm proximal of the proximal markerband and extended distally along the balloon for a total length of 7mm.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination of the hypotube/shaft found no kinks or damages.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.No other issues were identified during the product analysis.

• 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: 16059657
• MDR Text Key: 306741526
• Report Number: 2124215-2022-54871
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

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 Expiration Date: 05/24/2024
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0029466717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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