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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE COYOTE¿ ES CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939134152010
Device Problems Shaft; Break; Difficult to Remove; Catheter
Event Date 10/11/2017
Event Type  Injury  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4).

 
Event Description

It was reported that catheter removal difficulties were encountered and shaft break occurred. The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa). After a non-bsc guidewire crossed the anterior tibial artery, a 1. 5mm x 20mm x 142cm coyote¿ es balloon catheter was advanced and performed four dilatations for 180 seconds. When it was tried to be removed, severe resistance was met. When it was pulled out as it is, the part that was nearly 10cm from the tip of the balloon catheter was broken. The non-bsc guidewire also got separated into two. The detached balloon catheter and guidewire were all retrieved using a snare. The procedure was completed with this device. No patient complications nor injuries were reported.

 
Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a coyote es balloon catheter in two pieces and the broken non-bsc guidewire that is referenced in the event description. The balloon is loosely folded with blood in the inflation lumen and balloon. The shaft, hypotube, and bonds were microscopically and visually examined. The inner shaft is completely separated 132. 9cm from the strain relief. The outer shaft is completely separated 134. 7cm from the strain relief. The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces. There is tip damage. 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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).

 
Event Description

It was reported that catheter removal difficulties were encountered and shaft break occurred. The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa). After a non-bsc guidewire crossed the anterior tibial artery, a 1. 5mm x 20mm x 142cm coyote es balloon catheter was advanced and performed four dilatations for 180 seconds. When it was tried to be removed, severe resistance was met. When it was pulled out as it is, the part that was nearly 10cm from the tip of the balloon catheter was broken. The non-bsc guidewire also got separated into two. The detached balloon catheter and guidewire were all retrieved using a snare. The procedure was completed with this device. 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 - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6996758
Report Number2134265-2017-10584
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/11/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/24/2019
Device MODEL NumberH74939134152010
Device Catalogue Number39134-15201
Device LOT Number20685645
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/16/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/26/2017
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: 11/02/2017 Patient Sequence Number: 1
Treatment
GUIDEWIRE: CARDINAL HEALTH CHEVALIER FLOPPY
INFLATION DEVICE: SHEENMAN INFLATOR
INTRODUCER SHEATH: DESTINATION TERUMO 6F45
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