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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 Break (1069); Difficult to Remove (1528); Material Rupture (1546); Stretched (1601); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that removal difficulties, balloon rupture, and shaft break occurred. The patient underwent percutaneous transluminal angioplasty (pta) for graft occlusion after bypass from the superficial femoral artery to the popliteal. The stenosed target lesion was located in the moderately tortuous and non calcified below the knee vessel. A 4f introducer sheath was positioned. After crossing the wire, the anterior tibial artery (ata) and posterior tibial artery (pta) were dilated with 2. 0 x 4 coyote balloon catheter. A 4mm x 40mm x 146cm coyote es balloon catheter was then used to dilate the trunk section. There was no resistance noted during balloon delivery. The 4mm x 40mm x 146cm coyote es balloon catheter was deflated and there was resistance noted during removal of the balloon catheter from the lesion. At that time, the 4mm x 40mm x 146cm coyote es balloon catheter ruptured and the shaft broke. The introducer sheath was changed to 6f, and the separated 4mm x 40mm x 146cm coyote es balloon catheter was retrieved with a snare. In retrieving the 4mm x 40mm x 146cm coyote es balloon catheter, the shaft was elongated and twisting was also observed. The procedure was completed and no patient complications nor injuries 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 Key12885290
MDR Text Key281354554
Report Number2134265-2021-14349
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 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0027762202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/02/2021
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: 11/29/2021 Patient Sequence Number: 1
Treatment
GUIDEWIRE: GLADIUS; INTRODUCER SHEATH: 4F 25CM
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