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 Entrapment of Device (1212)

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

Event Date 06/10/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that the balloon was stuck with the guidewire.The target lesion was located the in the moderately calcified vessel.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was stuck with the non-boston scientific guidewire.The devices were removed as a unit and the procedure was completed.There were no patient complications reported.

Manufacturer Narrative

E1 - initial reporter address1: (b)(6).The device was returned for analysis.A visual examination identified that the balloon was not tightly wrapped and had 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 hypotube.No issues were noted with shaft polymer extrusion.A 0.014 guidewire is required for use as per wolverine instructions for use and a guidewire was loaded without issue.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was reported that the balloon was stuck with the guidewire.The target lesion was located the in the moderately calcified vessel.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was stuck with the non-boston scientific guidewire.The devices were removed as a unit and the procedure was completed.There were no patient complications reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14919143
• MDR Text Key: 303555350
• Report Number: 2134265-2022-07395
• 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,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/06/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028508258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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