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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 (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2020
Event Type  Malfunction  
Manufacturer Narrative

Device evaluation by mfr. : gladiator device - 7x40x75cm was received for analysis. A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure. Blood was identified within the balloon which is evidence of a device leak. A microscopic examination identified a balloon longitudinal tear beginning at the proximal bond and extending approximately 20mm distally across the balloon material. An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint. A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident. A visual and tactile examination found no kinks or damage to the shaft of the device. A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident. No issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 14aug2020. It was reported that crossing difficulty was encountered. The target lesion was located in the radial artery. A 7. 0 x40, 75cm gladiator 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 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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10503252
MDR Text Key206152142
Report Number2134265-2020-12474
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK132810
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 09/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/08/2020
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 Number0023935718
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/04/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/11/2019
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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