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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 H74939186301010
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 11/14/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that product sterility was compromised. A 3. 0mm x 100mm x 150cm coyote balloon catheter was selected for use. However, during unpacking, it was noticed that the inner packaging was opened and the device was considered unsterile. The device was never used in the patient. No patient complications were reported.
 
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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 Key7081903
MDR Text Key93825993
Report Number2134265-2017-11812
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111295
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberH74939186301010
Device Catalogue Number39186-30101
Device Lot Number19180678
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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