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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 Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : a gladiator device was returned for analysis. A visual examination identified that the balloon was damaged and had detached from the shaft of the device. A circumferential tear was identified in the balloon material 15mm distal from the proximal balloon sleeve. A visual and microscopic examination observed that the tip was attached to the balloon section that detached from the balloon material. A visual and tactile examination found the inner balloon shaft had detached. There was also severe stretching noted on the inner balloon shaft. There were also multiple shaft kinks noted along the balloon inner shaft. An examination of the markerbands identified that both markerbands had moved on the shaft due to the severe shaft stretching.
 
Event Description
Reportable based on additional information received on 12-nov-2021. It was reported that balloon damage occurred. Vascular stenosis was located in the stoma site. A 6. 0 x40, 40cm gladiator balloon catheter was selected for use. During priming, the balloon was damaged. The procedure was completed with another of same device. There were no patient complications reported and the patient status was stable. However, it was further reported that the device was used inside the patient, balloon leak was noted during inflation, and shaft detachment was noted only after procedure.
 
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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 Key12917954
MDR Text Key281665511
Report Number2134265-2021-14732
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0025875109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2020
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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