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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STINGRAY CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE STINGRAY CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number H749M1000A0
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by manufacturer: the device was returned for analysis. The outer shaft, inner shaft, balloon and tip were microscopically examined. The proximal marker and distal marker were present. There was no damage. Visual and microscopic inspection of the device was unable to identify any damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).

 
Event Description

Same case as mdr id: 2134265-2016-10907. It was reported that the device was not visible under fluoroscopy. The chronic totally occluded target lesion was located in the right coronary artery (rca). A stingray catheter was selected for use. During procedure the device was inserted into the patient; however, it was noted that the device was unable to be visualized under fluoroscopy even after contrast was introduced. The procedure was not completed due to this event. No patient complications were reported.

 
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Brand NameSTINGRAY CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
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 Key6137186
MDR Text Key61191747
Report Number2134265-2016-10906
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK080987
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 11/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2017
Device MODEL NumberH749M1000A0
Device Catalogue NumberM-1000-A
Device LOT Number17708082
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/19/2015
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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