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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 H74939135254010
Device Problems Shaft; Break
Event Date 01/15/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the iliac artery. A 2. 5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced for dilatation. However, the balloon delivery shaft fractured at the exchange port. A snare was then used to remove the fractured part but failed. Subsequently, a surgery was performed to remove the fractured part. No patient complications were reported and the patient's status was stable.

 
Manufacturer Narrative

Returned device consisted of a coyote es balloon catheter in 2 pieces. The balloon was tightly folded. Microscopic and tactile inspection revealed numerous kinks in the hypotube. The hypotube was fractured 72. 5cm from the strain relief, with a partial separation 12cm proximally from the exit notch/port. There were numerous kinks in the hypotube. The fracture faces were oval as if kinked prior to separation. Microscopic inspection found no irregularities or defects to the tip. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

 
Event Description

It was reported that shaft break occurred. The target lesion was located in the iliac artery. A 2. 5mm x 40mm x 146cm coyote¿ es balloon catheter was advanced for dilatation. However, the balloon delivery shaft fractured at the exchange port. A snare was then used to remove the fractured part but failed. Subsequently, a surgery was performed to remove the fractured part. No patient complications were reported and the patient's status was stable.

 
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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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5393082
Report Number2134265-2016-00456
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/15/2016
Device MODEL NumberH74939135254010
Device Catalogue Number39135-25401
Device LOT Number16027598
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/20/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2013
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/27/2016 Patient Sequence Number: 1
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