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 Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that balloon fracture occurred.The 20mmx2.0mm, 95% stenosed target lesion was located in the moderately calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was fractured and could not be used.The procedure was completed with another of the same device.There were no complications, and the patient is stable.

Event Description

It was reported that balloon fracture occurred.The 20mmx2.0mm, 95% stenosed target lesion was located in the moderately calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was fractured and could not be used.The procedure was completed with another of the same device.There were no complications, and the patient is stable.It was further reported that as per physician's opinion, the quality of the device might have caused the fracture.Also, upon removal a non-boston scientific guiding was used and inserted deeply, and the cutting balloon was removed slowly and smoothly without any difficulty encountered.

Event Description

It was reported that balloon fracture occurred.The 20mmx2.0mm, 95% stenosed target lesion was located in the moderately calcified left circumflex artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was fractured and could not be used.The procedure was completed with another of the same device.There were no complications, and the patient is stable.It was further reported that as per physician's opinion, the quality of the device might have caused the fracture.Also, upon removal a non-boston scientific guiding was used and inserted deeply, and the cutting balloon was removed slowly and smoothly without any difficulty encountered.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The following attributes were examined: visual/tactile inspection revealed that a visual and tactile examination identified a break in the hypotube shaft, located approximately 61.5cm distal from the strain relief.Further analysis identified multiple kinking along the hypotube.A visual and tactile examination identified no kinks or damages on shaft polymer extrusion.Microscopic analysis revealed that a detailed microscopic examination of the balloon material identified no damage to the balloon.A microscopic examination of the blades identified no damages.All blades were fully bonded onto the balloon.No issues were identified during a microscopic examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal marker bands identified no damage.

• 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: 16865382
• MDR Text Key: 314535697
• Report Number: 2124215-2023-21608
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2023

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: 0030289954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/03/2023; 07/05/2023
• Supplement Dates FDA Received: 05/16/2023; 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 72 KG