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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001PCB8020500
Device Problems Cutter/Blade; Material Deformation
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.

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON®
Type of DeviceCATHETER, 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 Key5359588
Report Number2134265-2015-09462
Device Sequence Number1
Product CodeLIT
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 Received01/12/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/23/2017
Device MODEL NumberM001PCB8020500
Device Catalogue NumberPCB802050
Device LOT Number18228606
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/29/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/31/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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