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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 H74939186251010
Device Problem Material Twisted/Bent (2981)
Patient Problem Occlusion (1984)
Event Date 01/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). Age at time of event: 18 years or older. (b)(4).
 
Event Description
It was reported that clot formation occurred. Vascular access was obtained via the right femoral artery using a 6f introducer sheath. The 70-80% stenosed, mildly calcified, moderately tortuous, eccentric and de novo target lesion was located in the popliteal artery to the tibial artery. The lesion did not allow for sufficient antegrade blood supply to the distal part of the right lower limb. After a 6f mach1 guide catheter and a 300cm victory 14 guide wire crossed to the lesion, a 2. 5mm x 100mm x 150cm coyote¿ balloon catheter was advanced without any issues until the segment of the popliteal artery. The physician wanted to advance the device more distally but could not do so since only half of the guide catheter was inside the patient and the length of the balloon was insufficient. The physician decided to remove the guide catheter and advance the balloon further with the use of the guide wire only. Subsequently, the balloon was able to advance and reach the tibial artery. Dilatation was then performed several times at different segments without any issues. Contrast medium was injected several times with much effort through the lumen of the coyote¿ balloon catheter to carry out control images and improvement in blood flow was noted. The physician then decided to advance the guide wire more distally but was unable to do so due to the curve at the tip of the guide wire. The guide wire was then removed to check its tip, leaving only the coyote¿ balloon catheter inside the patient's body. After checking, the guide wire was re-advanced through the hypotube of the balloon catheter but great resistance was encountered. Without success to advance the guide wire, the physician decided to remove the guide wire and the coyote¿ balloon catheter. It was then noted that the segment of the hypotube between the radiopaque markers of the balloon was totally twisted which caused the failure of the guide wire to advance through the coyote¿ balloon catheter. After a few minutes, a clot formation was noted in the popliteal artery. An attempt was made to extract the clot with a thrombus extracting device but was unsuccessful causing the clot to become bigger and move about 10mm towards the femoral artery, completely losing the antegrade blood flow to the rest of the lower limb. Subsequently, an attempt to recover the flow by doing a ¿plastisol¿ using a resterilized coronary balloon was performed but was unsuccessful. They physician then decided to finally finish the procedure and try to dissolve the clot through pharmacological management. No further patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr. , eval summary attached, method codes, result codes, conclusion codes updated. Device evaluated by mfr: returned product consisted of a coyote balloon catheter. The balloon was loosely folded with blood in the wire lumen and fluid in the balloon. The tip, balloon, markerbands, inner/outer shaft (lumen) were microscopically and tactile inspected. Inspection revealed inner damage (stretched) for approximately 56 mm located inside of the balloon, and an inner perforation located 47 mm from the tip of the device. Functional testing was done by loading a lab supplied. 014¿ guide wire into the hub of the device and advancing through the inner shaft. The wire advanced smoothly until the location of the inner damage (stretched), and the tip of the wire protruded out from a perforation in the inner. 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 clot formation occurred. Vascular access was obtained via the right femoral artery using a 6f introducer sheath. The 70-80% stenosed, mildly calcified, moderately tortuous, eccentric and de novo target lesion was located in the popliteal artery to the tibial artery. The lesion did not allow for sufficient antegrade blood supply to the distal part of the right lower limb. After a 6f mach1 guide catheter and a 300 cm victory 14 guide wire crossed to the lesion, a 2. 5 mm x 100 mm x 150 cm coyote¿ balloon catheter was advanced without any issues until the segment of the popliteal artery. The physician wanted to advance the device more distally but could not do so since only half of the guide catheter was inside the patient and the length of the balloon was insufficient. The physician decided to remove the guide catheter and advance the balloon further with the use of the guide wire only. Subsequently, the balloon was able to advance and reach the tibial artery. Dilatation was then performed several times at different segments without any issues. Contrast medium was injected several times with much effort through the lumen of the coyote¿ balloon catheter to carry out control images and improvement in blood flow was noted. The physician then decided to advance the guide wire more distally but was unable to do so due to the curve at the tip of the guide wire. The guide wire was then removed to check its tip, leaving only the coyote¿ balloon catheter inside the patient's body. After checking, the guide wire was re-advanced through the hypotube of the balloon catheter but great resistance was encountered. Without success to advance the guide wire, the physician decided to remove the guide wire and the coyote¿ balloon catheter. It was then noted that the segment of the hypotube between the radiopaque markers of the balloon was totally twisted which caused the failure of the guide wire to advance through the coyote¿ balloon catheter. After a few minutes, a clot formation was noted in the popliteal artery. An attempt was made to extract the clot with a thrombus extracting device but was unsuccessful causing the clot to become bigger and move about 10 mm towards the femoral artery, completely losing the antegrade blood flow to the rest of the lower limb. Subsequently, an attempt to recover the flow by doing a ¿plastisol¿ using a resterilized coronary balloon was performed but was unsuccessful. They physician then decided to finally finish the procedure and try to dissolve the clot through pharmacological management. 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 Key6281442
MDR Text Key65896520
Report Number2134265-2017-00353
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Model NumberH74939186251010
Device Catalogue Number39186-25101
Device Lot Number17939792
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2015
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: 01/26/2017 Patient Sequence Number: 1
Treatment
GUIDE CATHETER: 6F MACH 1; GUIDE WIRE: VICTORY 14 300CM
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