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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); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/11/2022
Event Type  Injury  
Event Description
It was reported that balloon rupture and tip detachment occurred. The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. A 2. 5mm x 20mm x 144cm coyote es balloon catheter was advanced for dilatation. However, during the first inflation at 14 atmospheres for 5 seconds, the balloon ruptured. During removal, it was noted that the balloon distal marker did not move and so separation was suspected. The device was pulled slowly but the distal tip was detached. The physician attempted to snare the detached tip but was unsuccessful. The procedure was completed with a different device. No further complications were 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 Key13433149
MDR Text Key285045818
Report Number2134265-2022-00512
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0026581192
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/02/2022 Patient Sequence Number: 1
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