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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 H74939135304010
Device Problems Shaft; Break; Difficult to Remove; Catheter
Event Date 01/26/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that removal difficulties were encountered and shaft break occurred. Vascular access was obtained with ipsilateral approach. The 100% stenosed, 35x6mm target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa). Following the deployment of a stent, a 3mm x 40mm x 146cm coyote¿ es balloon catheter was advanced with a non-bsc guide wire and was inflated 15 times at 6 atmospheres for 30 seconds each inflation. However, when withdrawal was attempted, the device became stuck in the guide catheter. The device was eventually removed and it was noted under fluoroscopy that the balloon catheter was separated and only the shaft was removed with the separated balloon part remaining inside the patient. A gooseneck snare was advanced and successfully retrieve the remaining balloon part. Both the balloon and the snare were removed. The device was checked outside the patient and it was noted that the balloon separated at the monorail exit port. The procedure was completed with a sterling es and 2. 0mm x 40mm x 144cm coyote¿ es balloon catheters. No patient complications were reported and the patient's status was fine.

 
Manufacturer Narrative

Device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by mfr: returned device consisted of a coyote es balloon catheter (in two pieces) and a guide wire, with blood and contrast in the balloon and lumen. The balloon was loosely folded. The returned device soaked in a warm water bath for 4 days. Microscopic inspection of the returned guide wire revealed damage (numerous kinks) to the proximal end of the wire. Microscopic inspection revealed damage (flared end) to the tip of the device. Microscopic inspection revealed severe bunching of the distal end of the balloon. Microscopic inspection found no irregularities with the bond of the device. Microscopic inspection revealed numerous kinks in the distal shaft and the inner shaft. The inner shaft had separated at 26cm from the tip and the outer shaft separated 22 cm from the tip. Additional damage was caused by a guide wire ripping through the inner shaft for 1. 5cm and outer shaft 7 cm, distal of the port/exit notch. The separated ends of the inner and outer shafts were also severely stretched. Microscopic inspection on the port/exit notch revealed damage due to stretching, with additional damage caused by the guide wire ripping through the entire notch area. 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 removal difficulties were encountered and shaft break occurred. Vascular access was obtained with ipsilateral approach. The 100% stenosed, 35x6mm target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa). Following the deployment of a stent, a 3mm x 40mm x 146cm coyote es balloon catheter was advanced with a non-bsc guide wire and was inflated 15 times at 6 atmospheres for 30 seconds each inflation. However, when withdrawal was attempted, the device became stuck in the guide catheter. The device was eventually removed and it was noted under fluoroscopy that the balloon catheter was separated and only the shaft was removed with the separated balloon part remaining inside the patient. A gooseneck snare was advanced and successfully retrieve the remaining balloon part. Both the balloon and the snare were removed. The device was checked outside the patient and it was noted that the balloon separated at the monorail exit port. The procedure was completed with a sterling es and 2. 0mm x 40mm x 144cm coyote es balloon catheters. No patient complications were reported and the patient's status was fine.

 
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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 Key5459760
Report Number2134265-2016-01029
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device MODEL NumberH74939135304010
Device Catalogue Number39135-30401
Device LOT Number18141596
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/02/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/29/2015
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: 02/25/2016 Patient Sequence Number: 1
Treatment
GUIDING CATHETER:DESTINATION
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