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

Model Number 3822

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: flextome cb monorail 10/3.00mm was returned for analysis.A visual inspection of the balloon identified a longitudinal tear present in the balloon material.The tear was located at 2mm proximal from the distal markerband and extended proximally for 1mm in length.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 marker bands.

Event Description

Reportable based on device analysis completed on 16dec2020.It was reported that inflation failure occurred.The 90% stenosed target lesion was located in the left anterior descending artery.A 10/3.00 flextome coronary cutting balloon was selected for use.During procedure, the balloon failed to inflate and no visible pinhole was noted in the balloon material.The device was removed within the catheter and the procedure was completed with a different device.There were no patient complications reported and the patient's status was stable.However, returned device revealed a balloon longitudinal tear located at 2mm proximal from the distal markerband and extended proximally for 1mm in length.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11038326
• MDR Text Key: 222396440
• Report Number: 2134265-2020-18057
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024877416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60