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 Break (1069)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that a device fracture occurred.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During unpacking, it was noted that the device was fractured.The procedure was completed with a different device.There were no patient complications reported post procedure.

Manufacturer Narrative

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

Event Description

It was reported that a device fracture occurred.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During unpacking, it was noted that the device was fractured.The procedure was completed with a different device.There were no patient complications reported post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).The device was returned for analysis.Visual, tactile, and microscopic analysis were performed on the device.A visual examination of the balloon identified no damages.Multiple hypotube kinks were noted along the shaft of the device and a break was identified, 51.7cm distal to the distal end of the strain relief.No kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during 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: 18091706
• MDR Text Key: 327616181
• Report Number: 2124215-2023-61489
• 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: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0030366302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG