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

Model Number 3822

Device Problems Failure to Advance (2524); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2020

Event Type  malfunction  

Event Description

It was reported that the balloon was torn.The 80% stenosed, 10mm x 2.5mm target lesion was located in the severe plaque load with calcified nodules and mildly calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon could not cross the lesion.Consequently, the balloon was torn at 10atm due to the calcified lesion.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.Visual examination identified that there was a build-up of blood inside the balloon.This is consistent with a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking in the proximal transition zone in the balloon.Microscopic examination of the balloon material identified no issues which could have contributed to the pinhole leak.The balloon pinhole most likely occurred when the balloon met a restriction of a severely calcified stenosed lesion.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 other issues were identified during device analysis.

Event Description

It was reported that the balloon was torn.The 80% stenosed, 10mm x 2.5mm target lesion was located in the severe plaque load with calcified nodules and mildly calcified left anterior descending artery.A 10/2.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon could not cross the lesion.Consequently, the balloon was torn at 10atm due to the calcified lesion.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: 10829893
• MDR Text Key: 215978620
• Report Number: 2134265-2020-15780
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0025436282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 68