MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number M001BPM4015140F0

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

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a balloon separation occurred.The target lesion was located in a shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During the procedure, the physician had difficulty removing the balloon protector.Subsequently, the balloon became separated from the device.The procedure was completed with a different device.No patient complications reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned balloon protector inner dimension was verified to be within specification.Specification for the inner diameter of the balloon protector was also within specification.A visual examination of the catheter noted that the balloon detached from the outer at the proximal balloon sleeve.The distal sleeve on the balloon had also detached from the tip location.The detached balloon is evident of excessive force having been applied to the balloon during the withdrawal of the balloon protector.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that a balloon separation occurred.The target lesion was located in a shunt.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During the procedure, the physician had difficulty removing the balloon protector.Subsequently, the balloon became separated from the device.The procedure was completed with a different device.No patient complications reported and the patient's condition was good.

• Brand Name: SMALL PERIPHERAL 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: 6119606
• MDR Text Key: 60624049
• Report Number: 2134265-2016-10353
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 18982669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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