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

Model Number H749CBM3350150

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned for analysis.A visual and tactile examination identified severe stretching and kinking damage beginning 250mm proximal to the tip on the shaft polymer extrusion.The damage was noted to extend proximally along the shaft for 180mm.No issues were noted with the shaft that could have contributed to the complaint incident.The balloon was observed to be unfolded which indicates it had been subjected to positive pressure.Blood was identified in the balloon and inflation lumen which is evidence of a device leak.A visual and microscopic examination identified a longitudinal tear in the balloon material approximately 4.5mm distal to the distal edge of the proximal markerband and extending distally across the balloon material for approximately 6mm.No issues were noted with the balloon material that could have contributed to the complaint incident.The markerbands, blades and tip section of the device were visually and microscopically examined and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.Multiple kinks were noted along the length of the hypotube.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 20-oct-2017.It was reported that shaft got stretched.A 3.50mm x 15mm flextome® cutting balloon® was selected for use.It was noted that the shaft got stretched and did not function properly.No patient complications were reported.However, device analysis revealed that the balloon was torn longitudinally.

• 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: 7011645
• MDR Text Key: 92596031
• Report Number: 2134265-2017-10901
• 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
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749CBM3350150
• Device Catalogue Number: CBM335015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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