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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STINGRAY LP CATHETER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION STINGRAY LP CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 10595
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2019
Event Type  Malfunction  
Manufacturer Narrative

The device was returned for analysis. The shaft, hypotube, tip and balloon were microscopically and visually examined. Contrast was present in the inflation lumen and balloon and blood in the guidewire lumen. Inspection of the device revealed that there was a balloon pinhole at the distal end of the balloon. Functional testing was performed by attaching an inflation device filled with water to the device. When positive pressure was applied, a stream of water emitted from the hole in the balloon. The presence of contrast in the inflation lumen and balloon and the fact that water was able to emit from the balloon hole during analysis, confirms that contrast was able to be injected through the device during the procedure. Inspection of the device presented no other damage or irregularities.

 
Event Description

Reportable based on device analysis completed on 07may2019. It was reported that the contrast could not be injected. The chronic totally occluded target lesion was located in the right middle coronary artery. A stingray lp catheter was selected for use. During procedure, it was noted that the contrast agent could not be injected into the device and the procedure was not completed. No complications reported and the patient condition was stable. However, device analysis revealed a balloon pinhole.

 
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Brand NameSTINGRAY LP CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8641290
MDR Text Key146093180
Report Number2134265-2019-05777
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK080987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 05/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/06/2020
Device MODEL Number10595
Device Catalogue Number10595
Device LOT Number0022621005
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/29/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/07/2018
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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