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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); Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
It was reported that catheter entrapment on guidewire and shaft break occurred. Vascular access was gained with ipsilateral antegrade approach. The 99% stenosed target lesion was located in the non-tortuous and moderately calcified distal superficial femoral artery. The guidewire lumen of a 3mm x 40mm x 146cm coyote es balloon catheter was flushed and advanced for dilation. However, during the procedure, the device got stuck on the guide wire. The device remained stuck during an attempt to remove it. The device was pulled by force and it got separated. There are no remains inside the body because the event occurred outside the body. The procedure was completed with a different device. No patient complication nor injuries reported.
 
Manufacturer Narrative
(b)(6).
 
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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 Key13660892
MDR Text Key286573483
Report Number2134265-2022-01723
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
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24691
Device Catalogue Number24691
Device Lot Number0028030148
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2021
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: 03/03/2022 Patient Sequence Number: 1
Treatment
GUIDEWIRE - JUPITER FC; INTRODUCER SHEATH - 6FR
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