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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH II 8F; INTRODUCER CATHETER, PRODUCT CODE: DYB, PRODUCT CODE: DYB

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OSCOR INC. SAFESHEATH II 8F; INTRODUCER CATHETER, PRODUCT CODE: DYB, PRODUCT CODE: DYB Back to Search Results
Model Number SS8
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
It was reported that a safesheath introducer broke right at the hub instead of peeling away as designed, a cutter was used to remove the introducer out of the patient - no issue for patient, but was difficult to get out.
 
Manufacturer Narrative
The device was used in treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.However, the following controls are in place to mitigate the reported product issue.Per procedure (adelante-s introducer sheath in process and final inspection) break and peel test: using samples from fit check manually break the sheath and hub and verify that the seal splits easily without extreme elongation.Also verify that the split cap and seal remain secure and do not break free or loosen from the sheath hub.Manually peel the sheath and verify the sheath peels easily along the sheath body and tip.Per ifu: sharply snap the tabs of valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel sheath apart while withdrawing from the vessel.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.
 
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Brand Name
SAFESHEATH II 8F
Type of Device
INTRODUCER CATHETER, PRODUCT CODE: DYB, PRODUCT CODE: DYB
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer Contact
doug myers
3816 desoto blvd.
palm harbor, FL 34683-1816
7279372511
MDR Report Key12226526
MDR Text Key263480232
Report Number1035166-2021-00074
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00802526532474
UDI-Public00802526532474
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSS8
Device Catalogue NumberSS8
Device Lot NumberDP12030
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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