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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 30aug2023.It was reported that a kink occurred.The target lesion was located in the severely tortuous and severely calcified obviously bent left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was kinked and damaged.The procedure was completed with another of the same device.No complications were reported, and the patient status was stable.However, device analysis revealed a break located at 21.9cm distal to the distal end of the strain relief.

Manufacturer Narrative

Device evaluated by mfr.: a visual and tactile examination of the device was received in two sections as a result of a break in the hypotube.The break was located at 21.9cm distal to the distal end of the strain relief.A visual and tactile examination identified multiple kinking along both sections of the hypotube.A microscopic examination of the balloon, blades, shaft polymer extrusion profile and tip found no damages.

Event Description

Reportable based on device analysis completed on 30aug2023.It was reported that a kink occurred.The target lesion was located in the severely tortuous and severely calcified obviously bent left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was kinked and damaged.The procedure was completed with another of the same device.No complications were reported, and the patient status was stable.However, device analysis revealed a break located at 21.9cm distal to the distal end of the strain relief.It was further reported that the device was not advanced violently, but the cutting balloon did not cross the lesion.

Manufacturer Narrative

Device evaluated by mfr.: a visual and tactile examination of the device was received in two sections as a result of a break in the hypotube.The break was located at 21.9cm distal to the distal end of the strain relief.A visual and tactile examination identified multiple kinking along both sections of the hypotube.A microscopic examination of the balloon, blades, shaft polymer extrusion profile and tip found no damages.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17717855
• MDR Text Key: 323392576
• Report Number: 2124215-2023-49212
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030663811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG