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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939186401010
Device Problems Shaft; Break
Event Date 05/27/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Bsc id: (b)(4). Tw: (b)(4).

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the tibial artery. A 4. 0mm x 100mm x 150cm coyote¿ balloon catheter was advanced to dilate the lesion. However, during introduction, it was noted that the hypotube was detached and the physician did not reach to put the balloon into the patient. A sterling balloon catheter was used and completed the procedure. No patient complications were reported and the patient's status was excellent.

 
Manufacturer Narrative

Device evaluated by mfr. : returned product consisted of a coyote balloon catheter. The balloon is loosely folded with contrast in the lumen and blood in the guidewire lumen and blood on the outside of the balloon. Although it was reported that the device was not used, the presence of blood and contrast media in the guidewire lumen is indicative of handling beyond simply unpackaging the device, as was reported. The hypotube and shaft was microscopically examined. The outer shaft is separated/torn 3mm from the hub. The fractured/separated end of the distal shaft is stretched and jagged which indicates the shaft separation was due to tensile forces. There is a hole in the outer shaft next to the separation. The inner shaft is buckled in numerous locations which is consistent with the damage seen with the use of a guidewire. The tip is damaged. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the tibial artery. A 4. 0mm x 100mm x 150cm coyote¿ balloon catheter was advanced to dilate the lesion. However, during introduction, it was noted that the hypotube was detached and the physician did not reach to put the balloon into the patient. A sterling balloon catheter was used and completed the procedure. No patient complications were reported and the patient's status was excellent.

 
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Brand NameCOYOTE¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key7692450
Report Number2134265-2018-06201
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939186401010
Device Catalogue Number39186-40101
Device LOT Number21635375
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/19/2018
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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