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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 M001PCB80201350
Device Problems Cutter; Detachment Of Device Component; Device Damaged Prior to Use
Event Date 11/25/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that the blade detachment occurred. A 135cm x 8. 00mm x 2. 0cm peripheral cutting balloon® was selected for use. During preparation, the blade of the balloon was detached. The device did not enter the patient's body. The procedure was completed with another of the same device and no patient complications were reported.

 
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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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6176949
Report Number2134265-2016-11572
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/25/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/05/2018
Device MODEL NumberM001PCB80201350
Device Catalogue NumberPCB8020135
Device LOT Number19678013
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/30/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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