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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR, INC. DESTINO TWIST STEERABLE GUIDING SHEATH INTRODUCER, CATHETER

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OSCOR, INC. DESTINO TWIST STEERABLE GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
We do not have this product on sight. None of our department was affected by this recall. Fda safety report id# (b)(4).
 
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Brand NameDESTINO TWIST STEERABLE GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR, INC.
MDR Report Key13366908
MDR Text Key284633158
Report NumberMW5107011
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

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