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 Material Puncture/Hole (1504)

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

Event Date 04/07/2023

Event Type  malfunction  

Event Description

It was reported that a hole in the shaft occurred.A 10mmx2.50mm was selected for use.During the procedure, it was noted that the wire came out from the part other than the wire exit port.The procedure was completed with another of the same device.There were no patient complications reported post procedure.

Event Description

It was reported that the wire came out from the part other than the wire exit port.A 10mmx2.50mm was selected for use.During the procedure, it was noted that the wire came out from the part other than the wire exit port.The procedure was completed with another of the same device.There were no patient complications reported post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was in a deflated state.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.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 tactile examination of the hypotube identified no kinks or damages.A visual and microscopic examination identified bunching to the wire lumen.This bunching was located at 5cm proximal from the tip.A microscopic examination of the lumen identified clear bunching in the inner/wire lumen.Further microscopic examination of the extrusion found a perforation in the outer lumen, at the site of the bunched inner.Due to the lumen damage, it was not possible to pass a recommended 0.014inch size wire through the wire lumen.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16787039
• MDR Text Key: 313758113
• Report Number: 2124215-2023-19220
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028726476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2022
• 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