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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 Date 06/06/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the balloon was not visible under fluoroscopy. A stingray catheter was selected for a chronic total occlusion (cto) procedure. During use, it was noted that the balloon was not visible under fluoroscopy. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. The balloon, shaft and hub were microscopically examined and no damage or irregularities identified. The device was successfully prepped. There was no evidence of any damage or irregularities contributing to the reported markerband visibility, which could not be validated because the clinical circumstances could not be replicated. 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 the balloon was not visible under fluoroscopy. A stingray catheter was selected for a chronic total occlusion (cto) procedure. During use, it was noted that the balloon was not visible under fluoroscopy. 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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5899420
MDR Text Key52837782
Report Number2134265-2016-07538
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,Followup
Report Date 07/28/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2017
Device MODEL NumberH749M1000A0
Device Catalogue NumberM-1000-A
Device LOT Number18664403
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/23/2015
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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