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 Break (1069); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) university.

Event Description

It was reported that the device was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx3.50mm wolverine cutting balloon was selected for use.During the procedure, the delivery shaft of the balloon was fractured 20cm from the hub, and it could not cross.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

Event Description

It was reported that the device was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery (lad).A 10mmx3.50mm wolverine cutting balloon was selected for use.During the procedure, the delivery shaft of the balloon was fractured 20cm from the hub, and it could not cross.The device was completely removed from the patient's body and the procedure was completed with another of the same device.No complications were reported and the patient was stable after the procedure.

Manufacturer Narrative

E1 - initial reporter facility name: the first affiliated hospital of zhengzhou university device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.Multiple kinks were noted along hypotube shaft.No kinks or damages were noted along polymer shaft.Multiple kinks were noted in various locations along the length of the hypotube shaft.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.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: 18685204
• MDR Text Key: 335124972
• Report Number: 2124215-2024-07889
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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 Expiration Date: 09/01/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030078630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 77 KG