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 Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 05jan2022.It was reported that the balloon was unable to cross into the catheter guide extension.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was unable to cross into the catheter guide extension.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that a 3mm distal section of the blade and pad were found to be lifted from the surface of the balloon.

Manufacturer Narrative

(b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon wings were found to be in a wrapped state.There were no issues noted with the balloon material.A microscopic examination of the blades identified the following issues on one blade: a 3mm distal section of the blade and pad were found to be lifted from the surface of the balloon.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.No issues were noted.A visual and tactile examination was completed, and no issues were noted with the shaft polymer extrusion of this device.The guidezilla guide catheter used in conjunction with this device was also returned with the device.An examination of this guidezilla found the tip of the guide was slightly compromised.Due to the blade damage noted on the wolverine device, the analyst was unable to load the wolverine device through the supplied guidezilla guide catheter.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13290226
• MDR Text Key: 284118642
• Report Number: 2134265-2022-00416
• 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
• Report Date: 01/19/2022

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: 09/02/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027958920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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
• Treatment: GUIDE EXTENSION: GUIDEZILLA II 6FR