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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 Failure to Advance
Event Date 12/10/2018
Event Type  Malfunction  
Manufacturer Narrative

The complaint device was returned for analysis. A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure. A visual and microscopic examination was performed on the returned gladiator device. A visual and microscopic examination of the returned device identified a longitudinal tear in the balloon material beginning at the distal edge of the proximal markerband, the tear extended distally over the balloon material for approximately 44mm. No issues were noted with the balloon material that could have contributed to the balloon material damage identified. No damage or any issues were noted with the tip of the device. A visual and microscopic examination found no issue with the markerbands which could have contributed to the complaint incident. A visual and tactile examination identified multiple kinks along the length of the device. This type of damage is consistent with excessive force being applied to the delivery system. No issues were noted with the shaft that could have contributed to the damage identified. No other issues were noted with the device.

 
Event Description

Reportable based on device analysis completed on (b)(6) 2019. It was reported that crossing difficulties were encountered. A 7. 0x40, 75cm gladiator elite balloon catheter was advanced but failed to cross the lesion. The procedure was completed with another of the same device. No patient complications were reported and the patient status was stable. However, returned device analysis revealed a longitudinal balloon tear.

 
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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 Key8387025
Report Number2134265-2019-01967
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/04/2019
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 Number0021687804
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2018
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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