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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 M001BP50620B0
Device Problems Cutter/Blade (777); Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years old and above. (b)(4) device evaluated by manufacturer: the device was returned for analysis. No tears or holes were identified in the balloon. The balloon was not refolded. An examination of the balloon found that 6mm of the proximal end of the blade was lifted on the balloon. The main section of pad was still attached to the balloon. The remaining three 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. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors. (b)(4).

 
Event Description

Reportable based on device analysis completed on 27-feb-2017. It was reported that blade of balloon was bent. A 6mmx2cmx50cm peripheral cutting balloon¿ was selected for use. During withdrawal of balloon, after using the device to treat blood removal failure, it was noted that the blade was deformed. No patient complications reported and patient's status was stable. However, device analysis revealed that 6mm of the proximal end of the blade was lifted on the balloon.

 
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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 Key6403882
MDR Text Key69911871
Report Number2134265-2017-02067
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 02/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated By Manufacturer? Yes
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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