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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 H74939135152010
Device Problems Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546)
Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
Event Date 11/24/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: returned device consisted of a coyote es balloon catheter in two pieces. There was blood and contrast in the balloon, wire lumen and inflation lumen. The tip, balloon, markerbands, proximal weld, inner/outer shaft, port/exit notch were microscopically, tactile and visually inspected. Inspection revealed; a complete separation (stretched) in the shaft (outer and inner shafts) located just distal of the port/exit notch (24 cm from the tip), numerous kinks in the distal shaft, balloon bunching with the distal end of the balloon prolapsing near the tip, tip damage (stretched/shredded), and port weld damage (stretched/focally necked/top of port ripped). Functional testing could not be performed due to the excessive damage to the device. Inspection of the remainder of the device revealed no other damage or irregularities. The reported information indicates the device was inflated over rated burst pressure. The physician intentionally inflated balloon over rated burst pressure in an effort to remove the device from the patient¿s anatomy. 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 difficulty, shaft break, balloon deflation failure, balloon rupture and blood flow reduction occurred. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified eccentric posterior tibial artery and distal part with a reference vessel diameter of about 2. 0-2. 5mm. A 3. 3fr non-bsc introducer sheath was placed to the same side of the popliteal artery by ipsilateral antegrade approach, and then two non-bsc guidewires were placed. A non-bsc 2. 0-100mm balloon catheter was advanced but unable to cross the lesion. Then a 1. 5mmx20mmx143cm coyote balloon catheter was advanced and pre-dilation was performed at 6 atm for 60 seconds. Then the device was caught by the calcification and it could not be moved at all. Thus the distal plantar artery was punctured and a non-bsc guidewire was approached to the tip of the trapped device to try to push it up, but it could not be moved. After that the balloon was inflated up to more than the rated burst pressure to rupture the balloon since the balloon was not fully deflated. But it still could not be removed even after pulling the shaft. About 20cm distal part of the shaft was detached and it remained inside the patient's body. The procedure was ended. Distal bypass surgery is scheduled at a later date due to decrease in blood flow. 7 days later surgical operation was performed successfully. The distal part of the posterior tibial artery was opened surgically. The detached balloon and distal tip were removed. Then, bypass graft was performed using the patient¿s vein to the distal part of the posterior tibial artery. The patient¿s status was stable.
 
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4).
 
Event Description
It was reported that removal difficulty, shaft break, balloon deflation failure, balloon rupture and blood flow reduction occurred. The 90% stenosed target lesion was located in the moderately tortuous and severely calcified eccentric posterior tibial artery and distal part with a reference vessel diameter of about 2. 0-2. 5mm. A 3. 3fr non-bsc introducer sheath was placed to the same side of the popliteal artery by ipsilateral antegrade approach, and then two non-bsc guidewires were placed. A non-bsc 2. 0-100mm balloon catheter was advanced but unable to cross the lesion. Then a 1. 5mmx20mmx143cm coyote balloon catheter was advanced and pre-dilation was performed at 6 atm for 60 seconds. Then the device was caught by the calcification and it could not be moved at all. Thus the distal plantar artery was punctured and a non-bsc guidewire was approached to the tip of the trapped device to try to push it up, but it could not be moved. After that the balloon was inflated up to more than the rated burst pressure to rupture the balloon since the balloon was not fully deflated. But it still could not be removed even after pulling the shaft. About 20cm distal part of the shaft was detached and it remained inside the patient's body. The procedure was ended. Distal bypass surgery is scheduled at a later date due to decrease in blood flow. 7 days later surgical operation was performed successfully. The distal part of the posterior tibial artery was opened surgically. The detached balloon and distal tip were removed. Then, bypass graft was performed using the patient¿s vein to the distal part of the posterior tibial artery. 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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7118062
MDR Text Key263362338
Report Number2134265-2017-12377
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K080982
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 11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberH74939135152010
Device Catalogue Number39135-15201
Device Lot Number20413171
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/17/2017
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: 12/14/2017 Patient Sequence Number: 1
Treatment
ASTATO 9-12 AND PROMINENT GUIDEWIRE; CRUISE 014 GUIDEWIRE; ICHIBANYARI PAD2 GUIDEWIRE; INFLATION DEVICE: ENCORE 26; INTRODUCER SHEATH: PARENT 3.3FR; MASTULY 2.0-100MM
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