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 Difficult to Remove (1528); Material Rupture (1546); Material Integrity Problem (2978)

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

Event Date 06/07/2022

Event Type  malfunction  

Event Description

It was reported that a balloon was difficult to remove and perforated.The 90% stenosed target lesion was an area of in-stent restenosis (isr) located in the moderately tortuous vessel.A 10mmx 2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, after dilatation was performed, the middle part of the device was stuck on the tip of the guide catheter when pulled out.Considering that the balloon appeared to be flattened upon deflation, it was attempted to inflate once at 12atm but the device was perforated in a pinhole form and could not be inflated.Per the physician, since it was stuck in the middle of the wolverine balloon part, it was thought that the guide catheter tip might have been stuck by on the flexpoint in the middle of the blade.It was then attempted to push and rotate the device and the device was able to be removed completely.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

D4: updated lot# to 29190775.Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state with media present inside the inflation lumen.The balloon exhibited signs of having been inflated.The device was soaked in a water bath at 37 degrees celsius in order to dissolve the solidified media and facilitate balloon inflation.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied when a pinhole leak was identified in the balloon material.The pinhole was located in the mod-body of the balloon.A visual and microscopic examination identified no issues with the balloon matrerial which could have contributed to the pinhole leak.All blades were fully bonded with no damage visible.A visual and microscopic examination identified that the inner/wire lumen of the device was found to be accordioned at 2.5 cm proximal to the proximal balloon cone.As a result of this damage, it was not possible to load a 0.014 inch wire passed the wire lumen damaged site.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was reported that a balloon was difficult to remove and perforated.The 90% stenosed target lesion was an area of in-stent restenosis (isr) located in the moderately tortuous vessel.A 10mmx 2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, after dilatation was performed, the middle part of the device was stuck on the tip of the guide catheter when pulled out.Considering that the balloon appeared to be flattened upon deflation, it was attempted to inflate once at 12atm but the device was perforated in a pinhole form and could not be inflated.Per the physician, since it was stuck in the middle of the wolverine balloon part, it was thought that the guide catheter tip might have been stuck by on the flexpoint in the middle of the blade.It was then attempted to push and rotate the device and the the device was able to be removed completely.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14834253
• MDR Text Key: 301834010
• Report Number: 2134265-2022-07150
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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 Expiration Date: 04/06/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029190775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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
• Treatment: GUIDE CATHETER - JL3.5 TERUMO 6F; GUIDE CATHETER - JL3.5 TERUMO 6F