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 01/10/2024

Event Type  malfunction  

Event Description

It was reported that the balloon became stuck on the guidewire.The right coronary artery contained a 60% stenosed target lesion in the middle segment and a more than 90% stenosed target lesion in the distal segment.A 10 mm x 2.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, the device became stuck on the guidewire and could not be advanced to the target lesions.The device was removed along with the wire.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 right coronary artery contained a 60% stenosed target lesion in the middle segment and a more than 90% stenosed target lesion in the distal segment.A 10 mm x 2.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, the device became stuck on the guidewire and could not be advanced to the target lesions.The device was removed along with the wire.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 and tactile examination, microscopic analysis and device to device interaction testing performed.A hypotube break was noted at 43.5cm distal to the distal end of the strain relief.Multiple kinks were noted in various locations along the length of the hypotube shaft.Examination of the balloon identified no damages.Tip showed no signs of tip damage.No kinks or damages to the shaft polymer extrusion.No tears or pinholes in the balloon material.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No damages noted to the proximal and distal markerbands.The device was successfully tracked over a recommended 0.014'' guidewire.

• 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: 18646265
• MDR Text Key: 334762723
• Report Number: 2124215-2024-04449
• 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

• Date FDA Received: 02/05/2024
• 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: 0032049080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 54 KG