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 Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(4).Age at time of event: 18 years or older.

Event Description

It was reported that malposition of markerband occurred.The target lesion was located in the left anterior descending artery.A 10mm x 2.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the placement of marker is wrong.The marker was on the mid segment of the balloon instead of at the end of the balloon.The procedure was completed with another of same device.There were no complications reported and patient is stable.

Manufacturer Narrative

A1 patient identifier (b)(6).A2.Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon folds were tightly wrapped and indicated that the balloon had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found the proximal marker band to be positioned at 4mm proximal to the distal marker band.Marker bands for wolverine product are required to align with the balloon shoulder as per wolverine specification.The investigator removed the balloon material.No cracks or damage was noted to the proximal marker band.The proximal marker could be moved along the tip of the device but would not be considered loose.A visual and tactile examination found no damage or issues with shaft of the device.

Event Description

It was reported that malposition of markerband occurred.The target lesion was located in the left anterior descending artery.A 10mm x 2.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the placement of marker is wrong.The marker was on the mid segment of the balloon instead of at the end of the balloon.The procedure was completed with another of same device.There were no complications reported and patient is stable.

• 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
• MDR Report Key: 10571038
• MDR Text Key: 208132221
• Report Number: 2134265-2020-12901
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0025684924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1