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 Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).

Event Description

It was reported that the tip was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately left anterior descending artery (lad).A 10 mm x 3.50 mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During the procedure, the catheter could not cross lesion and it was noted that the tip of the device was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.

Manufacturer Narrative

E1: (b)(6).

Event Description

It was reported that the tip was fractured.The 95% stenosed target lesion was located in the moderately tortuous and moderately left anterior descending artery (lad).A 10 mm x 3.50 mm wolverine coronary cutting balloon was selected for percutaneous coronary intervention (pci).During the procedure, the catheter could not cross lesion and it was noted that the tip of the device was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.It was further reported that the fractured tip has been removed from the patient's body.

• 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: 18715131
• MDR Text Key: 336197515
• Report Number: 2124215-2024-08411
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: 0031364961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 88 KG