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

Model Number 3852

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the blade was lifted.The target lesion was located in a non-tortuous and mildly calcified vessel.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, lesion was dissociated moderately and good dilation was obtained.However, it was noted that the blade was away from the balloon upon removal.Both proximal/distal ends of the blade were still attached to the balloon but the middle area was lifted.No blade detachment and no perforation occurred but the middle part seems to be in a "<" shape.Device replacement was not performed, and the procedure was completed as it was.No complications reported and the patient was in good condition post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface however the following blade damage was noted: blade 1: damage noted on the proximal blade segment: 2 mm of the blade segment was found to be missing from the blade pad.No issues noted with the pad.Blade 2: damage noted on the middle blade segment.Both segment ends were found to be lifted from the pad.Blade 3: damage noted on the middle blade segment.Both segment ends were found to be lifted from the pad.A visual and tactile examination identified multiple hypotube kinks.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 the blade was lifted.The target lesion was located in a non-tortuous and mildly calcified vessel.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, lesion was dissociated moderately and good dilation was obtained.However, it was noted that the blade was away from the balloon upon removal.Both proximal/distal ends of the blade were still attached to the balloon but the middle area was lifted.No blade detachment and no perforation occurred but the middle part seems to be in a "<" shape.Device replacement was not performed, and the procedure was completed as it was.No complications reported and the patient was in good condition post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was not returned for analysis.Analysis of the photograph confirmed the evidence of a lifted blade i the proximal segment of a blade.

Event Description

It was reported that the blade was lifted.The target lesion was located in a non-tortuous and mildly calcified vessel.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, lesion was dissociated moderately and good dilation was obtained.However, it was noted that the blade was away from the balloon upon removal.Both proximal/distal ends of the blade were still attached to the balloon but the middle area was lifted.No blade detachment and no perforation occurred but the middle part seems to be in a "<" shape.Device replacement was not performed, and the procedure was completed as it was.No complications reported and the patient was in good condition 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; two scimed place; maple grove MN 55311
• MDR Report Key: 11685275
• MDR Text Key: 246010345
• Report Number: 2134265-2021-04977
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2021

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: 12/09/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026490760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/07/2021; 06/03/2021
• Supplement Dates FDA Received: 05/20/2021; 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1