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

Model Number 3822

Device Problems Material Rupture (1546); Material Separation (1562)

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

Event Date 06/02/2021

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified left main artery.A 10/4.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon burst at 2atm inside the patient and they could no longer use it.The device was removed directly and the procedure was completed with another of same 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 examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.No tears or holes were visible in the balloon.Blood was evident inside the balloon material.The device was attached to an encore inflation device and positive pressure was applied.A pinhole leak was identified at the distal end of the distal marker band.An examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination found multiple hypotube kinks along the device.A visual and tactile examination identified no issues with the shaft polymer extrusion.

Event Description

It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified left main artery.A 10/4.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon burst at 2atm inside the patient and they could no longer use it.The device was removed directly and the procedure was completed with another of same 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: 12025859
• MDR Text Key: 257224176
• Report Number: 2134265-2021-07860
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0025511186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 70