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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24686
Device Problem Defective Device
Event Date 12/14/2018
Event Type  Malfunction  
Manufacturer Narrative

Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. The returned device was attached to an encore inflation unit. Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 10mm proximal of the proximal markerband. An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint. The rated burst pressure for this device is 14 atmospheres. A visual and microscopic examination found no issues with the markerbands or tip of the device that could have contributed to the complaint incident. A visual and tactile examination identified multiple kinks at various locations along its length. These kinks are consistent with excessive force having been applied to the shaft. No other issues were noted with the device during analysis.

 
Event Description

Reportable based on device analysis completed on 15-feb-2019. It was reported that device damage occurred. During unpacking of a 12. 0 x40, 75cm gladiator elite balloon catheter, it was noted that the device was damaged. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed balloon pinhole.

 
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Brand NameGLADIATOR ELITE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI 
Manufacturer Contact
sonali arangil
two scimed place
maple grove , MN 55311
6515827403
MDR Report Key8413968
Report Number2134265-2019-02288
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number24686
Device Catalogue Number24686
Device LOT Number0021984631
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/12/2018
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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