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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. ADELANTE MAGNUM INTRODUCER SET WITH HEMOSTATIC VALVE INTRODUCER, CATHETER

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OSCOR INC. ADELANTE MAGNUM INTRODUCER SET WITH HEMOSTATIC VALVE INTRODUCER, CATHETER Back to Search Results
Model Number ASM016030
Device Problem Break (1069)
Patient Problems Calcium Deposits/Calcification (1758); Stenosis (2263); No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  malfunction  
Manufacturer Narrative
Conclusion not yet available - evaluation in progress. This initial mdr is being submitted to meet our requirements of reporting. A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
The patient was scheduled for a caradic surgery procedure (transcatheter aortic valve replacement), and during the procedure the sheath was broken while exchanging out the sheath. This broke outside the patient's body and did not negatively impact this patient. No adverse patient effects were reported.
 
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Brand NameADELANTE MAGNUM INTRODUCER SET WITH HEMOSTATIC VALVE
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 34863
Manufacturer Contact
doug myers
3816 desoto blvd.
palm harbor, FL 34683
7279372511
MDR Report Key8363869
MDR Text Key137426942
Report Number1035166-2019-00013
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00885672004736
UDI-Public00885672004736
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140917
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2020
Device Model NumberASM016030
Device Catalogue NumberASM016030
Device Lot NumberC8-11865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2017
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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