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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 04/09/2015
Event Type  malfunction  
Event Description
It was reported that during the procedure the re-entry device was not visible on angiography. The target lesion was located in the mildly calcified mid circumflex artery. While performing a chronic total occlusion (cto), a stingray catheter was selected for use. Upon advancement, there was no visualization of the stingray balloon. The procedure was completed with another of the same device and no patient complications were reported.
 
Manufacturer Narrative
Age at time of event: 18 years or older. The complaint device was not received at the complaint investigation site (cis) for analysis. 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).
 
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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 Key4752053
MDR Text Key17204120
Report Number2134265-2015-02658
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/09/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2016
Device Model NumberH749M1000A0
Device Catalogue NumberM-1000-A
Device Lot Number17563957
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/29/2014
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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