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

Model Number 3852

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that a difficulty removal and device fracture occurred.The 90% stenosed target lesion was located in the proximal end of the left anterior descending artery (lad).A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, after the cutting balloon have treat the calcified lesion, it was withdrawn from the lesion, but resistance was relatively large.They slightly increase the force to withdraw, however the delivery shaft got fractured.The device was withdrawn manually, and the procedure was completed with another of the same device.There were no patient complications reported post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) medical.Device evaluated by manufacturer: visual, tactile, and microscopic analysis was performed on the device.Visual and tactile inspection reveale that the device was received in two sections as a result of a break in the hypotube.The break was located at 66cm distal to the distal end of the strain relief.No other issues were identified with the hypotube shaft.No kinks or damages were visible on shaft polymer extrusion.No tears were visible in the balloon material.The balloon material was folded.A microscopic examination of the break site identified no issues with the actual hypotube which could potentially have contributed to the break.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.There were no kinks or damages observed along the entire length of the distal extrusion and there was no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other damage was noted along the entire device.

Event Description

It was reported that a difficulty removal and device fracture occurred.The 90% stenosed target lesion was located in the proximal end of the left anterior descending artery (lad).A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, after the cutting balloon have treat the calcified lesion, it was withdrawn from the lesion, but resistance was relatively large.They slightly increase the force to withdraw, however the delivery shaft got fractured.The device was withdrawn manually, and the procedure was completed with another of the same device.There were no patient complications reported post procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18754560
• MDR Text Key: 336758463
• Report Number: 2124215-2024-07857
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0031545845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 70 KG