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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
Model Number DST0705509
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
 
Event Description
It was reported that the dilator was too short, and it did not fit into the sheath. The reported event occurred during the procedure. The physician used a new dilator to continue the procedure. No serious injury was reported. No additional information is available.
 
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Brand NameDESTINO TWIST STEERABLE GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd
palm harbor, FL 34683
7279372511
MDR Report Key11880578
MDR Text Key255570517
Report Number1035166-2021-00053
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K140406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDST0705509
Device Catalogue NumberDST0705509
Device Lot NumberC8-20437
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2020
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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