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 Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2022

Event Type  Injury  

Event Description

It was reported that the blade detached and could not be retrieved.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, inflation was performed after pre-dilation for about 9 times with the corresponding device, and high-pressure was applied up to 16atm.Subsequently, a good lumen was confirmed through imaging and a non-bsc stent was implanted.However, the blade was noted to be missing when checked after the case.The computed tomography (ct) and imaging were reviewed but unable to detect the blade.Per physician's opinion, the blade was probably crimped to the blood vessel with the stent.No further complications were reported, and patient was good post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.2 blades were present on the balloon surface however 1 blade was found to be missing - details as follows: no issues noted with blade 1 or 2 - blades secure in pads and pads fully adhered to balloon material.The blade 3 - blade missing and not returned - no issues noted with the pad.Pad intact and fully adhered to the balloon material.A visual and tactile examination identified no issues with the hypotube of this device.A visual, microscopic, and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was reported that the blade detached and could not be retrieved.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified proximal to mid left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, inflation was performed after pre-dilation for about 9 times with the corresponding device, and high-pressure was applied up to 16atm.Subsequently, a good lumen was confirmed through imaging and a non-bsc stent was implanted.However, the blade was noted to be missing when checked after the case.The computed tomography (ct) and imaging were reviewed but unable to detect the blade.Per physician's opinion, the blade was probably crippled to the blood vessel with the stent.No further complications were reported, and patient was good 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14892493
• MDR Text Key: 295224299
• Report Number: 2134265-2022-07158
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029277063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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
• Treatment: IMAGING CATHETER - ALTAVIEW; IMAGING CATHETER - ALTAVIEW
• Patient Outcome(s): Other