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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 Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2021
Event Type  malfunction  
Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
 
Event Description
It was reported that during implant of the pacing lead, the sheath did not split properly, leaving a small portion of the sheath attached to the pacing lead. One ear and small portion of the sheath barrel broke off before the sheath was split completely and removed the physician had to use a small kelly forceps to grasp the remaining part of the sheath and carefully manipulate the sheath barrel so it would split the rest of the way without damaging the pacing lead. The procedure was completed with no further issues.  no patient complications have been reported as a result of this event. No additional information is available.
 
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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
Manufacturer Contact
doug myers
3816 desoto blvd
palm harbor, FL 34683
7279372511
MDR Report Key12689599
MDR Text Key278149051
Report Number1035166-2021-00124
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
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 Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
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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