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

Model Number 3851

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A wolverine cb mr, ous 10mmx2.50mm was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however approximately 1mm of the proximal end of the blade and the pad were found to be lifted from the balloon material.A visual and tactile examination found a hypotube kink at 46.7 cm distal to the strain relief.No issues were noted with the tip or marker bands.

Event Description

Reportable based on device analysis competed on 17dec2020.It was reported that the device was unable to cross lesion.The target lesion area was located in a severely tortuous and severely calcified right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that the balloon was unable to cross and dilatation was achieved by a non-bsc balloon.Rotablator was performed with increase of the burr size and ablation was continued until 2.00.A 3.25 wolverine as inflated and with a non-bsc device entering calcification.Placement of stent was done.There were no patient complications reported.However, device analysis revealed that 1mm of the proximal end of the blade and the pad were found to be lifted from the balloon material.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11113370
• MDR Text Key: 225069120
• Report Number: 2134265-2020-18263
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2021

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: 09/11/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026003834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2020
• 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