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 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).

Event Description

It was reported that a device fracture occurred.The target lesion was located in the left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured.The procedure was completed with another wolverine coronary cutting balloon.There were no complications reported and the patient was stable post procedure.

Event Description

It was reported that a device fracture occurred.The target lesion was located in the left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured.The procedure was completed with another wolverine coronary cutting balloon.There were no complications reported and the patient was stable post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified a break in the hypotube shaft, located approximately 67.8cm distal from the strain relief.Further analysis identified a kink in the hypotube approximately 3cm proximal from the break site.A visual and tactile examination identified no kinks or damages on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in 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 markerbands 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: 17017208
• MDR Text Key: 316088833
• Report Number: 2124215-2023-25633
• 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: 07/16/2023

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: 0030905374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/29/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2023
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG