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

Model Number 3822

Device Problems Fracture (1260); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  malfunction  

Event Description

It was reported that the balloon fractured.A 10/2.75 flextome was selected for use.During introduction inside the patient, it was noted that the balloon fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

F10.Corrected device codes fracture 1260 to material rupture 1546.

Event Description

It was reported that the balloon fractured.A 10/2.75 flextome was selected for use.During introduction inside the patient, it was noted that the balloon fractured.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the target lesion was in the left anterior descending artery.The balloon burst upon first inflation and was not fractured.The device was then completely removed within the catheter without any intervention.

• 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: 9611855
• MDR Text Key: 178221495
• Report Number: 2134265-2020-00230
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024397109
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 75