MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3852

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

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

Event Date 04/03/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.A visual and tactile test found no issues with the hypotube of this device.A visual and microscopic examination found a tear/perforation in the extrusion at the guidewire exit port.No damage was noted on the tip of this device.It was possible to pass a recommended 0.014inch size wire through the tip and wire lumen with no resistance noted.The device was attached to a pre-tested encore inflation unit, using the druck gauge.During an attempt to inflate the balloon, liquid leaked out through the inner/wire lumen and flushed out through the tip.The leak is consistent with a breach between the inner and outer lumen.The leak location was confirmed at a tear/puncture in the extrusion at the guidewire exit port.It is likely that when the customer met with some restriction during the initial insertion of the guidewire, the guidewire punctured through the inner lumen into the outer, resulting in the catheter leak.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 26may2023.It was reported that there was a backflow of blood in the system.The 77% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician was unable to advance the wire and after attempting multiple times, the device crossed the wire.It was noted that there was a backflow of blood in the system.The procedure was completed with a non-boston scientific device.There were no patient complications reported.However, device analysis revealed a tear/perforation in the extrusion at the guidewire exit port.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17140071
• MDR Text Key: 317310708
• Report Number: 2124215-2023-28657
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0029635013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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 Race: Asian