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 03/18/2024

Event Type  malfunction  

Event Description

It was reported that the catheter shaft broke.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the delivery shaft was fractured.The device was completely removed from the patient's body with a guide catheter and the procedure was completed with another of the same device.No patient complications were reported, and patient is stable post procedure.

Event Description

It was reported that the catheter shaft broke.The 85% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the delivery shaft was fractured.The device was completely removed from the patient's body with a guide catheter and the procedure was completed with another of the same device.No patient complications were reported, and patient is stable post procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.No issues were noted with the hypotube shaft.The shaft polymer extrusion had 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.Bumper distal tip was crushed.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.

• 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: 19084876
• MDR Text Key: 340049850
• Report Number: 2124215-2024-21987
• 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: 05/14/2024

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 Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031867816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 62 KG