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

Model Number	SS6
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) 2024 - during a dual pacemaker/ generator change / new rv lead procedure another ep physician peeled away safe sheath ii from the lead, and the disc did not split in half.The physician used scissors to cut the disc, and the safe sheath and disc were removed.No harm no injury to patient.There was no delay in the procedure.There was no medical or surgical intervention.The staff removed all product with the same lot number from the area.The procedure was completed successfully.At this time, we do not have either device.It was removed from my office and was possibly discarded.There are no picture or videos available.Complaint sent to fda by physician.Additional complaint: (b)(4).
Additional Manufacturer Narrative
No product was returned to oscor inc.For evaluation; however, a complaint notification was provided.The customer stated the facility does not have the product to return.Multiple attempts were made to confirm the product disposition.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.As per the event description, the disc did not split in half.The physician used scissors to cut the disc, and the safe sheath and disc were removed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.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.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.

• Brand Name: SAFESHEATH® II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor 34683
• Manufacturer Contact: ronnie greco ; 3816 desoto blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 19920365
• Report Number: 1035166-2024-00086
• Device Sequence Number: 18171145
• Product Code: DYB
• UDI-Device Identifier: 30891492002211
• UDI-Public: 30891492002211
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: SS6
• Device Catalogue Number: SS6
• Device Lot Number: DP-20958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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