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); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was folded.No damage was observed along the entire balloon.All blades were intact within their pads and fully bonded to the balloon material.The device was received in two sections as a result of a break in the hypotube.The break was located at 41.2cm distal from the strain relief.Multiple kinking was identified along both sections of the hypotube.A visual and tactile examination of the distal extrusion identified bunching along the inner lumen, proximal to the proximal markerband.The markerbands were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.An examination of the tip section of the device identified some tip damage at its distal end.The distal edge of the tip was distorted.

Event Description

Reportable based on device analysis completed on (b)(6) 2021.It was reported that the balloon was unable to cross the lesion, the tip was lifted and the shaft was kinked.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.During the procedure, it was noted that a resistance was felt on the proximal side when crossing the lesion.The device was removed without any issues and it was noted that the tip was lifted and the shaft was kinked.The procedure was completed with another of same device.No patient complications were reported and patient was good post procedure.However, device analysis revealed that a hypotube break.

• 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: 12002408
• MDR Text Key: 256460794
• Report Number: 2134265-2021-07738
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026699737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2021
• 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