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

Model Number 3820

Device Problems Inflation Problem (1310); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon wings had been subjected to positive pressure.The device was attached to an encore inflation unit and positive pressure was applied.Liquid was observed to be leaking from a balloon pinhole located approximately 3mm proximally 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.The rated burst pressure for this device is 12 atmospheres.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.No issues were noted with the hypotube/shaft of 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 30sep2020.It was reported that the balloon could not inflate and was damaged.The 80% stenosed target lesion was located in the right coronary artery.A 06/3.50 flextome cutting balloon was selected for use.During procedure, it was noted that the balloon could not inflate and was found damaged.The procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.However, device analysis revealed that there was balloon pinhole.

• 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: 10673125
• MDR Text Key: 211459113
• Report Number: 2134265-2020-14056
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0022287685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• 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: 61 YR
• Patient Weight: 60