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

Model Number 3851

Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2023

Event Type  Injury  

Event Description

It was reported that the balloon ruptured, a blade detached and additional intervention was necessary for removal.The target lesion was located in the highly calcified and diffusely lesioned first diagonal branch segment.The target lesion was predilated using 1.50 mm and 2.00 mm balloons before a 10 mm x 2.00 mm wolverine coronary cutting balloon was introduced for treatment.Difficulty was encountered during insertion of the device and the surgeon believed the device may have been caught in severe calcification.A non-boston scientific guide extension catheter was used to successfully store and remove the device, although difficulty was experienced.Upon inspection of the wolverine after removal, the shape of the balloon had collapsed considerably and a rupture was noted.Only two of three blades were visualized.Intravascular ultrasound could not be completed due to the condition of the vessels and the location of the detached blade could not be confirmed.The procedure was completed.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile inspection was performed.The balloon was returned with a v shaped tear measuring approximately 5mm in length.Multiple kinks were noted along the hypotube shaft.The polymer extrusion was stretched just proximal of the port exchange and a kink was noted in the distal extrusion at the guidewire exit port.A detailed microscopic examination of the balloon material identified v shaped tear measuring approximately 5mm in length.One set of the blades were detached, 8.5mm of the blades was not attached to the balloon and the remaining 1.5mm of the blade was attached to the castpad.A detailed microscopic examination confirmed that the blade castpad 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.Multiple kinks were noted along the hypotube shaft.A microscopic examination of the proximal and distal markerbands identified no damage.

Event Description

It was reported that the balloon ruptured, a blade detached and additional intervention was necessary for removal.The target lesion was located in the highly calcified and diffusely lesioned first diagonal branch segment.The target lesion was predilated using 1.50 mm and 2.00 mm balloons before a 10 mm x 2.00 mm wolverine coronary cutting balloon was introduced for treatment.Difficulty was encountered during insertion of the device and the surgeon believed the device may have been caught in severe calcification.A non-boston scientific guide extension catheter was used to successfully store and remove the device, although difficulty was experienced.Upon inspection of the wolverine after removal, the shape of the balloon had collapsed considerably and a rupture was noted.Only two of three blades were visualized.Intravascular ultrasound could not be completed due to the condition of the vessels and the location of the detached blade could not be confirmed.The procedure was completed.

• 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: 18262208
• MDR Text Key: 329668622
• Report Number: 2124215-2023-66238
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030353888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female