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

Model Number 3850

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported that the device was difficult to remove.A 2.50 x 6 mm wolverine was advanced with resistance and became stuck in the blood vessel.The device was removed and replaced with another wolverine balloon.The procedure was completed with no patient injury.

Event Description

It was reported that the device was difficult to remove.A 2.50 x 6 mm wolverine was advanced with resistance and became stuck in the blood vessel.The device was removed and replaced with another wolverine balloon.The procedure was completed with no patient injury.It was further reported that a 2.50 x 23 mm non-boston scientific stent was previously implanted in the left main trunk to the left anterior descending artery.Intravascular lithotripsy (ivl) was performed to prepare the in-stent lesion before introducing the 2.50 x 6 mm wolverine.After deflation of the balloon, the device became stuck.Strong resistance was felt during removal and the distal part of the device detached and remained within the patient.The flow was bad temporarily, but dilatation was performed again and the device fragment was covered by another stent recovering the flow.The patient was stable post-procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Visual/tactile inspection and microscopic analysis was performed.No issues identified with the hypotube shaft.Multiple kinks and stretching were identified along the polymer extrusion.The inner wire lumen was stretched and a break was identified 10mm distal from the proximal markerband with the distal section of the break, including the tip was not returned.A complete circumferential tear occurred in the balloon.The tear was located approximately 2mm distal from the proximal markerband.Examination of the proximal markerband noted that it was pulled distally due to the stretching of the inner wire lumen.The distal section of the balloon tear was not returned.Examination of the blades identified one proximal segment of blade was attached (approximately 5mm in length).The remaining blades were not returned.No other device issues were identified during returned product analysis.

Event Description

It was reported that the device was difficult to remove.A 2.50 x 6 mm wolverine was advanced with resistance and became stuck in the blood vessel.The device was removed and replaced with another wolverine balloon.The procedure was completed with no patient injury.It was further reported that a 2.50 x 23 mm non-boston scientific stent was previously implanted in the left main trunk to the left anterior descending artery.Intravascular lithotripsy (ivl) was performed to prepare the in-stent lesion before introducing the 2.50 x 6 mm wolverine.After deflation of the balloon, the device became stuck.Strong resistance was felt during removal and the distal part of the device detached and remained within the patient.The flow was bad temporarily, but dilatation was performed again and the device fragment was covered by another stent recovering the flow.The patient was stable post-procedure.

• 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: 18188008
• MDR Text Key: 328959446
• Report Number: 2124215-2023-65983
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0031704420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/29/2023; 02/22/2024
• Supplement Dates FDA Received: 12/08/2023; 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2023
• 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 Outcome(s): Required Intervention