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

Model Number 3822

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the delivery shaft fractured.A 10/2.75 flextome cutting balloon was selected for use.During preparation, when the device was being unpacked, it was noted that the cutting balloon's delivery shaft was fractured, and the device could not be used.The procedure was completed with another of the same device.No complications reported, and the patient was stable.

Event Description

It was reported that the delivery shaft fractured.A 10/2.75 flextome cutting balloon was selected for use.During preparation, when the device was being unpacked, it was noted that the cutting balloon's delivery shaft was fractured, and the device could not be used.The procedure was completed with another of the same device.No complications reported, and the patient was stable.

Manufacturer Narrative

Initial reporter phone: (b)(6).Device evaluated by the manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned flextome cb monorail 10/2.75.The balloon wings were relaxed.A visual and microscopic examination found no issues with the balloon or blades.The tip section of the device was visually and microscopically examined, and no issues were noted with its profile.A visual and microscopic examination found no issue with the profile of the device markerbands.A visual and tactile examination identified a hypotube break at approximately 85 cm from the distal end of strain relief.Multiple hypotube kink were also identified along several locations of the hypotube shaft.The type of damages noted are consistent with excessive force that could have been applied to the delivery system.No issues were noted on the shaft polymer extrusion shaft.No other issues were identified during the product analysis.The directions for use states under preparation section that care should be taken not to kink or bend the shaft.

• 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: 8909942
• MDR Text Key: 154893098
• Report Number: 2134265-2019-09977
• 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: 09/10/2019

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: 02/04/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0023298100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 65