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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH II INTRODUCER, CATHETER

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OSCOR INC. SAFESHEATH II INTRODUCER, CATHETER Back to Search Results
Model Number SS7
Device Problems Break (1069); Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/23/2020
Event Type  malfunction  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up report will be submitted as soon as the investigation is complete.
 
Event Description
The issue is that the peel away did not peel in half, needed scissors to cut away the remaining sheath which required a two minute extension. The procedure was completed and no harm was done to the patient. There is a risk of damaging the intracardiac lead when scissors are used to trim away the excess sheath. The device was discarded.
 
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Brand NameSAFESHEATH II
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 Key10743221
MDR Text Key225929630
Report Number1035166-2020-00066
Device Sequence Number1
Product Code DYB
UDI-Device Identifier30891492002228
UDI-Public30891492002228
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS7
Device Catalogue NumberSS7
Device Lot NumberDP11590
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2020
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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