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

Model Number 3822

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Event Description

It was reported that the balloon core wire was fractured.The 85% stenosed, 24mmx3.0mm target lesion was located in the moderately tortuous and calcified left circumflex artery.A 10/2.50 flextome cutting balloon was selected for use.During preparation, when the physician unpacked the device, it was noted that the core wire was fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.An examination of the returned device identified that the balloon folds were still in place.The balloon material and 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.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 inspection of the device found a hypotube break at 100mm distally from the strain relief.No other issues were identified during the product analysis.

Event Description

It was reported that the balloon core wire was fractured.The 85% stenosed, 24mmx3.0mm target lesion was located in the moderately tortuous and calcified left circumflex artery.A 10/2.50 flextome cutting balloon was selected for use.During preparation, when the physician unpacked the device, it was noted that the core wire was fractured.The procedure was completed with another of the same device.No patient complications were reported and the 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: 10025270
• MDR Text Key: 190150841
• Report Number: 2134265-2020-06029
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• 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: 05/28/2020

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: 09/22/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024478260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 79