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

Model Number	SS7
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device will be returned for evaluation, as it was discarded by the customer.The introducer sheath was removed.No patient complications have been reported as a result of this event.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No product was returned to oscor inc.For evaluation; however, a complaint notification was provided.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.The instructions for use (ifu) adelante safesheath ii, informs the user: 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.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.
Event or Problem Description
It was reported that intra-operative the introducer sheath exhibited a severe peeling issue, which took a lot of effort, caused the pacing lead position to destabilize, and led to lead repositioning and a delay in the procedure, and longer time exposure of the pocket.The introducer sheath was removed.No patient complications have been reported as a result of this event.Device will not be returned for evaluation, as it was discarded by the customer.

• Brand Name: SAFESHEATH® II INTRODUCER SET
• Common Device Name: INTRODUCER, 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 19107492
• Report Number: 1035166-2024-00029
• Device Sequence Number: 7428158
• Product Code: DYB
• UDI-Device Identifier: 30891492002228
• UDI-Public: 30891492002228
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SS7
• Device Catalogue Number: SS7
• Device Lot Number: DP20742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown