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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 Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/24/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr.: returned device consisted of a coyote es balloon catheter with blood and contrast in the inflation lumen.The balloon was loosely folded.The balloon, markerbands, proximal weld and inner/outer shafts were microscopically and tactile inspected.Inspection revealed tip damage and a pinhole in the balloon material over the markerband.Functional testing was performed by connecting an inflation device filled with water to the hub.When pressure was applied, water was found to be leaking from the balloon.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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
Reportable based on device analysis completed on 20-jun-2018.It was reported that crossing difficulties were encountered.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.After a guide wire crossed the lesion, a 1.5mm x 20mm x 143cm coyote¿ es balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed balloon pinhole.
 
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Brand Name
COYOTE¿ ES
Type of Device
CATHETER, 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 Key7683566
MDR Text Key114027117
Report Number2134265-2018-06064
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,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/26/2021
Device Model NumberH74939135152010
Device Catalogue Number39135-15201
Device Lot Number21666395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2018
Initial Date FDA Received07/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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