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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 H74939185401510
Device Problems Shaft; Break; Difficult to Remove ; Catheter
Event Date 11/13/2017
Event Type  Injury  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4). The returned product consisted of a coyote balloon catheter in two pieces. The balloon was loosely folded with blood in the inflation lumen and balloon. The shaft, hypotube, and bonds were microscopically and visually examined. The shaft is completely separated 111. 6cm from the hub. The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces. There are numerous hypotube and shaft kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. 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 removal difficulties were encountered and shaft break occurred. Vascular access was obtained via ipsilateral antegrade approach. The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa). After a 6f non-bsc introducer sheath was advanced, a non-bsc guide wire was advanced but failed to cross along with another non-bsc guidewire. After a 9x40mm non-bsc guide wire was used at the proximal-cap, a truepath cto device successfully crossed the lesion. Body surface echo and intravascular ultrasound were used to visualize the lesion. The non-bsc introducer sheath did not completely enter in the sfa. When trying to advanced a 4. 0mm x 150mm x 150cm mr coyote¿ balloon catheter, the shaft got bent in the descending femoral artery. Without checking the bending of the shaft, the device was advanced into the lesion as it was and dilation was performed. Following dilation, the device could not be removed. Excessive force was applied and the hypotube got separated. The device was completely removed using a snare. A 4x4mm non-bsc balloon was advanced and dilated the lesion. A 6x15cm innova stent was deployed in the distal sfa and a 6x15cm non-bsc stent was deployed in the proximal sfa. Post dilation was performed using a non-bsc balloon and the procedure was completed. The physician stated that inflation and deflation of the coyote¿ balloon catheter was performed without issue. No further patient complications were reported and the patient's status was stable.

 
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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 Key7105507
Report Number2134265-2017-11747
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939185401510
Device Catalogue Number39185-40151
Device LOT Number21041473
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/17/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/28/2017
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: 12/11/2017 Patient Sequence Number: 1
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