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U.S. Department of Health and Human Services

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

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OSCOR INC. SAFESHEATH® II INTRODUCER SET INTRODUCER, CATHETER Back to Search Results
Model Number SS7
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
It was reported during the implant procedure, the introducer sheath would not peel. The hcp had to use surgical scissors to peel the sheath. The device issue was resolved by cutting the sheath. No surgical delay or extended hospitalization was reported. There was no patient side effects reported. No additional information is available.
 
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
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Brand NameSAFESHEATH® II INTRODUCER SET
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 Key12956371
MDR Text Key284868414
Report Number1035166-2021-00150
Device Sequence Number1
Product Code DYB
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 Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS7
Device Catalogue NumberSS7
Device Lot NumberDP13500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2021
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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