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 Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Event Description

It was reported that blade distortion occurred.The target lesion was located in a non calcified saphenous vein graft.The 10mmx2.75mm wolverine coronary cutting balloon was inflated below rated burst pressure, however, during second usage, it was noted that the blade was distorted and about to separate.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned wolverine cb mr, ous 10mm x 2.75mm device.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 5 mm in length was completely detached from the balloon material.The remaining section of the blade was undamaged and fully bonded to the balloon material.The detached section of blade was not returned for analysis.The complete pad of the blade remained fully bonded to the balloon material.The damage identified can potentially be a result of the resistance encountered during withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.There were no issues noted on the balloon that may have potentially contributed to the complaint incident during a visual and microscopic examination of the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found no issues with the shaft of the device.No issues were noted which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that blade distortion occurred.The target lesion was located in a non calcified saphenous vein graft.The 10mmx2.75mm wolverine coronary cutting balloon was inflated below rated burst pressure, however, during second usage, it was noted that the blade was distorted and about to separate.No patient complications were reported.It was further reported that the missing part of the broken catheter remained in the body.After removing the catheter, the physician did not realize that there was a missing section of the blade.

• 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
• MDR Report Key: 9282828
• MDR Text Key: 168286695
• Report Number: 2134265-2019-13438
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 0024022414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1