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

Model Number 3850

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that the blade was detached, following removal from the patient.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was used for a short 1-2mm circumferential segment-2 lesion.The 1.5mm rotapro and 1.25mm rotapro could not cross the lesion.A maximum atmospheric pressure of 12atm was applied, and there was no resistance advancing or removing the the device.Following removal from the patient, it was noted that the blade was detached and missing.It is unknown if there are device fragments remaining in the patient's body.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile inspection was performed, revealed that the balloon contrast media was inside the balloon.Multiple kinks were noted along the hypotube shaft.No kinks or damages on shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.One set of the blades was detached, 1.5mm of the blades was not attached to the complaint.A detailed microscopic examination confirmed that the blade castpads was fully intact.The other two sets of blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.

Event Description

It was reported that the blade was detached, following removal from the patient.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was used for a short 1-2mm circumferential segment-2 lesion.The 1.5mm rotapro and 1.25mm rotapro could not cross the lesion.A maximum atmospheric pressure of 12atm was applied, and there was no resistance advancing or removing the device.Following removal from the patient, it was noted that the blade was detached and missing.It is unknown if there are device fragments remaining in the patient's body.No patient complications were reported.

• 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: 18176246
• MDR Text Key: 328583386
• Report Number: 2124215-2023-63692
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0031712386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2023
• 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 Outcome(s): Required Intervention