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

Model Number 3820

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

Event Type  malfunction  

Event Description

It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.During preparation, the cutting balloon was unpacked, and it was found that the balloon was fractured.The procedure was completed with another of the same device.No patient complications reported.

Event Description

It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.(b)(6) 2020 during the procedure, the physician unpacked the cutting balloon, it was found the balloon was fractured.The procedure was completed with another of same device.There were no complications reported.It was further reported that the patient was fine post procedure.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).

• 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: 10428247
• MDR Text Key: 203831109
• Report Number: 2134265-2020-11265
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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: 12/09/2022
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0024905019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR