MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001PCB8020500

Device Problems Cutter/Blade (777); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that blade lifted occurred. The target lesion was located at subclavian vein. A 8. 00mmx2. 0cmx50cm peripheral cutting balloon® was selected to treat the target lesion. The pressure and duration of the total five inflations was unknown. On the fifth inflation, it was noted that the balloon ruptured and the blade was lifted off the balloon. No patients complications were reported and the patient was okay.

Manufacturer Narrative

Device evaluated by mfr. : the device was returned for evaluation. An examination of the device identified that a blade and pad had lifted off the balloon. The blade was still attached to the balloon. 5mm of the blade was attached from its distal end. A pinhole leak was identified at the distal end of a blade. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. No issues were noted on the shaft polymer extrusion profile. A visual and tactile examination of hypotube found no kinks or damage along the shaft of the 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 blade lifted occurred. The target lesion was located at subclavian vein. A 8. 00mmx2. 0cmx50cm peripheral cutting balloon® was selected to treat the target lesion. The pressure and duration of the total five inflations was unknown. On the fifth inflation, it was noted that the balloon ruptured and the blade was lifted off the balloon. No patients complications were reported and the patient was okay.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON®
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 5359588
• MDR Text Key: 35617360
• Report Number: 2134265-2015-09462
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/12/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 07/23/2017
• Device MODEL Number: M001PCB8020500
• Device Catalogue Number: PCB802050
• Device LOT Number: 18228606
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial