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

Model Number 3822

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

It was reported that the balloon burst.The 90% stenosed, 10mmx2.5mm target lesion was located in the calcified left circumflex artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon burst at standard pressure and was removed within the catheter.The procedure was completed with another of the same device.No complications reported and patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded.Solidified media was noted to be present in the balloon body and the device shaft.Inflation attempt was made, and the balloon failed to inflate.The device was placed in water-bath to soften the hardened media.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to rated burst pressure of 12 atmospheres to inflate the balloon and the balloon inflated with no issues.Pressure was held for 30 seconds (timed) and there was no drop in pressure or damage to balloon material noted.Inflation was repeated and completed three times with no issue.The inflation device was verified for functionality at to rated burst pressure of 12 atmospheres before and after use with druck pressure tester.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.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 of the shaft of the device identified no kinks or damages.No issues were identified during device analysis.

Event Description

It was reported that the balloon burst.The 90% stenosed, 10mmx2.5mm target lesion was located in the calcified left circumflex artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon burst at standard pressure and was removed within the catheter.The procedure was completed with another of the same device.No complications reported and patient was stable.

• 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: 10969823
• MDR Text Key: 220443075
• Report Number: 2134265-2020-17156
• 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: 01/15/2021

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: 06/30/2023
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0025654669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 53