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 01/09/2024

Event Type  malfunction  

Event Description

It was reported that the balloon became stuck on the guidewire.The 70-80% stenosed target lesion was located in the left anterior descending artery (lad).A 10 mm x 2.00 mm wolverine coronary cutting balloon was selected for pretreatment of the artery.During the procedure, it was noted that the device was stuck on the guidewire and could not be advanced to the target lesion.The device was removed with the guidewire.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Event Description

It was reported that the balloon became stuck on the guidewire.The 70-80% stenosed target lesion was located in the left anterior descending artery (lad).A 10 mm x 2.00 mm wolverine coronary cutting balloon was selected for pretreatment of the artery.During the procedure, it was noted that the device was stuck on the guidewire and could not be advanced to the target lesion.The device was removed with the guidewire.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual/tactile inspection, microscopic analysis and a device to device interaction test was performed.Device analysis confirmed that no issues existed with the inner/wire lumen.Using a 0.014inch size guidewire, the guidewire was tracked through the wire lumen with no resistance noted.Further analysis identified that a v-shaped longitudinal tear existed in the balloon material.The tear stretched either side of an entire blade segment.The blade and pad were fully bonded to the balloon material however, the section of the balloon material that was torn resulted, in a "flap" of balloon material, with the blade and pad attached, being raised off the balloon.No section of balloon or blade had detached from the balloon.No other damages were present.

• 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: 18647050
• MDR Text Key: 334676785
• Report Number: 2124215-2024-04448
• 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: 03/27/2024

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 Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0032197098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 61 KG