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

Model Number H749CBM3300100

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the catheter snapped.During procedure, after successfully dilating the lesion with a 2.0 x 10 and a 2.5 x 10 flextome balloon catheters, a 10/3.00 flextome® was used; however, the catheter snapped upon removal.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by mfr.,eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.The balloon protector cap was not returned for analysis.The device was received in two sections as a result of a break in the hypotube.The break was located at approximately 23.6cm distal from the strain relief.Both sections of the hypotube were kinked at various locations.An examination of the midshaft found that the shaft was kinked at 1cm proximal to the port.There was no damage noted to the tip, balloon, or blades.No tears or holes were noted in the balloon material.No other issues were noted with this device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that the catheter snapped.During procedure, after successfully dilating the lesion with a 2.0 x 10 and a 2.5 x 10 flextome balloon catheters, a 10/3.00 flextome® was used; however, the catheter snapped upon removal.No patient complications were reported and the patient's status was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6019978
• MDR Text Key: 57052718
• Report Number: 2134265-2016-08898
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

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: 06/08/2019
• Device Model Number: H749CBM3300100
• Device Catalogue Number: CBM330010
• Device Lot Number: 19347277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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