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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 SS6
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
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
During the procedure, the sheath was used for a single chamber pacemaker implant to introduce a solia s60 lead into the subclavian vein of the patient. The doctor was unable to split the sheath upon the last 5-6 mm, despite a lot of force applied. The doctor had to cut one side of the sheath to release the lead. The event did not cause an adverse change in the patient's condition. The patient was not subjected to procedures which might have damaged the device.
 
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Brand NameSAFESHEATH® II
Type of DeviceINTRODUCER, CATHETER
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
daniel naut
3816 desoto blvd.
palm harbor, FL 34683-1816
7279372511
MDR Report Key13593051
MDR Text Key286468637
Report Number1035166-2022-00029
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 07/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSS6
Device Catalogue NumberSS6
Device Lot NumberDP12780
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2021
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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