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

Model Number 3850

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual and microscopic 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 shaft break was located at 87cm distal to the distal end of the strain relief.Multiple kinking was identified along both sections of the hypotube.A visual and tactile examination of the distal extrusion identified no damage.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 no damage.

Event Description

Reportable based on device analysis completed on 10jan2023.It was reported that the device was kinked.The target lesion was located in the moderate to severely calcified mid and distal segment of the left anterior descending artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During unpacking, it was found that the device was kinked.The procedure was completed with another of the same device.No complications were reported and the patient's status was stable.However, returned device analysis revealed 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16234969
• MDR Text Key: 308569606
• Report Number: 2124215-2023-02693
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/24/2023

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: 02/15/2024
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0028871001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG