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

Model Number H749CBM3350150

Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blade detachment occurred.A 15/3.50 flextome® cutting balloon® was selected to be used.During preparation, it was noted that the atherotome came apart from the balloon.The procedure was completed with another device.No patient complications reported and patient's condition was fine.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for evaluation.An examination of the balloon and blades identified no anomalies.All the blades and pads were inspected and no issues were noted.All the blades were present on the balloon.As part of the device analysis the balloon was inflated to its rated burst pressure of 12 atmospheres with no leaks noted.The inflation device was verified at 12 atmospheres before and after use with a calibrated pressure gauge.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was reported that blade detachment occurred.A 15/3.50 flextome® cutting balloon® was selected to be used.During preparation, it was noted that the atherectomy came apart from the balloon.The procedure was completed with another device.No patient complications reported and patient's condition 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5571369
• MDR Text Key: 42498642
• Report Number: 2134265-2016-02780
• 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: 03/16/2016

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: 12/22/2018
• Device Model Number: H749CBM3350150
• Device Catalogue Number: CBM335015
• Device Lot Number: 0018755568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• 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