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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION COYOTE ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24691
Device Problems Material Rupture (1546); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that balloon rupture occurred. Vascular access was obtained utilizing a crossover approach. The 100% stenosed target lesion was located in the severely tortuous and severely calcified iliac artery. After the lesion was crossed with jupiter max guidewire, a 2mm x 20mm x 143cm coyote es balloon catheter was advanced but failed to cross the lesion. Subsequently, a 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced, but it also failed to cross the lesion. The crossover was discontinued and a change to the approach from the left bra was performed. After the lesion was crossed again with jupiter max guidewire, a 1. 5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation, however, during inflation at 8 atmospheres, the balloon ruptured. A 2mm x 20mm x 143cm coyote es balloon catheter was advanced, but it also ruptured during inflation. The procedure was completed with a 4mmx2cm coyote balloon catheter. There were no patient complications reported.
 
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Brand NameCOYOTE ES
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
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12750323
MDR Text Key280063108
Report Number2134265-2021-13865
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093636
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 11/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0026936959
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/09/2021
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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