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

Model Number 3822

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the coronary artery.A 10/3.00 flextome cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon burst at less than working pressure within few seconds.The device was simply pulled out from the patient's body and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual inspection identified solidified media in the balloon.An examination of the balloon identified no longitudinal tears present in the balloon material.The device was soaked in a water bath at 37 degrees celsius in order to soften the media and facilitate the balloon inflation.The device was attached to an encore inflation unit and during an attempt to inflate the balloon a pinhole leak was confirmed in the balloon material.The pinhole was located at 1mm distal from the proximal markerband.An examination of the balloon material identified no issues which could potentially have contributed to the pinhole.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found no issues present on the device.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the proximal or distal marker bands.No other issues were noted with the device.

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the coronary artery.A 10/3.00 flextome cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon burst at less than working pressure within few seconds.The device was simply pulled out from the patient's body and the procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.

• 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: 11118430
• MDR Text Key: 225281680
• Report Number: 2134265-2020-18777
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0025153746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 50