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 Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported that foreign material was present on the device upon opening a 10mmx3.00mm wolverine coronary cutting balloon from the packaging, it was observed that there was plastic on the proximal end of the balloon.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that foreign material was present on the device.Upon opening a 10mmx3.00mm wolverine coronary cutting balloon from the packaging, it was observed that there was plastic on the proximal end of the balloon.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination of the balloon identified no damage to the balloon.Loosely attached on the surface of the distal end of the balloon was a small (approximately 2mm long) fiber.This fiber detached from the balloon during analysis and could not be retrieved.The fiber is not consistent with the reported alleged green plastic foreign material reported under this complaint.The fiber does not correlate with the image received from the customer.The fiber likely attached to the balloon as part of device handling during shipping return and receipt to the analytical lab.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and microscopic examination of the hypotube identified no damage.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.A microscopic examination of the tip identified that the tip edge was jagged in appearance.

• 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: 15279453
• MDR Text Key: 300791661
• Report Number: 2124215-2022-32043
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 02/06/2023

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: 03/15/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029054711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• 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
• Patient Race: Asian