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 Deflation Problem (1149)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that the balloon deflation was slow.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that deflation issue occurred.After the device was inflated twice at 6atm for 20 seconds each, the balloon was removed but deflation took longer than usual within 5-10 seconds.The device was completely removed and the procedure was completed with another of the same device.No patient complications reported.

Event Description

It was reported that the balloon deflation was slow.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that deflation issue occurred.After the device was inflated twice at 6atm for 20 seconds each, the balloon was removed but deflation took longer than usual within 5-10 seconds.The device was completely removed and the procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: the wolverine device was returned for analysis.Visual, tactile, microscopic, functional and device-to-device interaction analysis was performed on the device.Several attempts were made to inflate the balloon.The inflation liquid had slowly reached the balloon and when an attempt was made to deflate the balloon, the balloon failed to deflate, confirming the reported event.The polymer extrusion was stretched which prevents the inflation liquid to inserted or removed from the balloon.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: 18231713
• MDR Text Key: 329495381
• Report Number: 2124215-2023-66575
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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: 0032310980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2023
• 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