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

Model Number 3822

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon leak occurred.A 10/3.00 flextome cutting balloon was selected for use.During preparation, it was noted that the balloon was leaking.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Event Description

It was reported that a balloon leak occurred.A 10/3.00 flextome cutting balloon was selected for use.During preparation, it was noted that the balloon was leaking.The procedure was completed with another of the same device.No complications were reported and the patient was stable post procedure.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.The following attributes were considered during analysis: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the distal end of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.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 markerbands.A visual and tactile examination identified no damage or kinks to the hypotube or shaft of the returned device.No other issues were identified during the product analysis.

• 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: 9638470
• MDR Text Key: 178394284
• Report Number: 2134265-2020-00519
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024378677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 58