MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3820

Device Problem Leak/Splash (1354)

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

Event Date 07/05/2021

Event Type  malfunction  

Event Description

It was reported that there were pinholes on the balloon.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 06/4.00 flextome cutting balloon was selected for use.It was noted that significant resistance was encountered during the procedure.The balloon was damaged as there were "little dots" (pinholes) noted and it could not be used.The device was removed directly and the procedure was completed with another of the same device.There were no complications reported and the patient was stable following the procedure.

Event Description

It was reported that there were pinholes on the balloon.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 06/4.00 flextome cutting balloon was selected for use.It was noted that significant resistance was encountered during the procedure.The balloon was damaged as there were "little dots" (pinholes) noted and it could not be used.The device was removed directly and the procedure was completed with another of the same device.There were no complications reported and the patient was stable following the procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was in a relaxed state with evidence of solidified media present in the inflation lumen.The device was placed in a water bath to allow the solidified media to soften to aid an inflation attempt.The device was attached to encore inflation device and during an attempt to inflate the balloon, a balloon pinhole leak was confirmed over the proximal markerband.No damage was observed to the balloon material which could have contributed to the pinhole leak.A visual and microscopic examination observed no damage to the markerbands, tip or blades.All blades were present and fully bonded to the balloon surface.No damage or any issues were noted with the markerbands, blades or tip that could have contributed to the complaint incident.A visual and tactile examination found no issues with the hypotube shaft.A visual and tactile examination found that there were no issues with the extrusion shaft.No other issues were identified with the returned device during the product analysis.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12243084
• MDR Text Key: 264064639
• Report Number: 2134265-2021-09657
• 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
• Report Date: 09/13/2021

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: 04/10/2022
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0023628052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 65