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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; Break
Event Date 03/24/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a blade was broken. The target lesion was located in a right upper extremity fistula. An 8. 00mm/2. 0cm/50cm peripheral cutting balloon was used to dilate the lesion. When the balloon catheter was pulled out of the patient, it was noted that the blade was broken. The procedure was completed with another of the same device. No patient complications were reported and the patient's condition was fine.

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. An examination of the device identified that a blade and pad had lifted off the balloon. The blade was still attached to the balloon. Eight mm of the blade was attached from its distal end. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. No issues were noted with its shaft polymer extrusion profile. A visual and tactile examination 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 a blade was broken. The target lesion was located in a right upper extremity fistula. An 8. 00mm/2. 0cm/50cm peripheral cutting balloon® was used to dilate the lesion. When the balloon catheter was pulled out of the patient, it was noted that the blade was broken. The procedure was completed with another of the same device. No patient complications were reported and the patient's condition was fine.

 
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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 Key5591440
Report Number2134265-2016-03460
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/20/2016
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 Manufacturer04/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2016
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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