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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 M001PCB8020900
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4).

 
Event Description

It was reported that the blade was lifted. A 2cm peripheral cutting balloon was selected for use. During withdrawal, upon pulling out the device from the patient, one of the atherotomes kind of came half way off. There were no patient complications reported and the patient's condition was fine.

 
Manufacturer Narrative

Device evaluated by mfr. : device was returned for analysis. Visual examination was done. No tears or holes were identified in the balloon. The balloon was not refolded. An examination of the balloon found that 1cm of the proximal to mid section of the blade was lifted on the balloon. The pad was intact. The remaining blades were inspected and no issues were noted. No issues were identified with the tip. A visual and tactile examination identified no damage along the entire length of the shaft. No other issues were identified during the product analysis. 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 the blade was lifted. A 2cm peripheral cutting balloon® was selected for use. During withdrawal, upon pulling out the device from the patient, one of the atherotomes kind of came half way off. There were no patient complications 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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6308116
MDR Text Key66772078
Report Number2134265-2017-00797
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/17/2017
Device MODEL NumberM001PCB8020900
Device Catalogue NumberPCB802090
Device LOT Number0018647554
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/04/2015
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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