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	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.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 during the implant procedure the introducer sheath rubber valve was not splitting properly and getting stuck to the lead.Multiple sheaths were attempted; however, regardless of size the same issue occurred.The sheaths were attempted, removed not replaced.No patient complications have been reported as a result of this event.All sheaths found to have the same issue.When peeling away the sheath after lead placement the valve does not detach properly.This results in the operator having to cut the valve off with scissors or scalpel.The risk is that the lead is dislodged, this could be serious if the patient is dependent on the lead after placement.External pacing may be needed.There is also the risk of needing to repeat the procedure with new venous access if the lead is damaged in the process of removing the valve.Customer would like one more lot added dor14006.Unopened packet of 5 sheaths but customer suspects will have same valve issue.Product expected to return.14/mar/2025 additional information received: the customer reported there was only a minute or so delay in the procedure.Mosquito scissors used to pull rubber valve apart to resolve the issue.Currently in transit.All five sheaths were unopened and not used.
Event or Problem Description
The customer reported that since there has been a delay in the return of the device, we can now consider it lost (will not be returned).
Additional Manufacturer Narrative
No product was returned to oscor inc.For evaluation as customer considers it lost; 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.Based on the information provided by the supporting documentation, "the introducer sheath rubber valve was not splitting properly and getting stuck to the lead.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.In conclusion, based on the information available at this time it cannot be confirmed that the product failed to meet requirements.The complaint is non-verifiable as the product was not returned for evaluation.Based on the investigation, capa-05374 was initiated to further investigation the reported issue.Lot number dor14006 was manufactured on 10/jan/2024 before capa-05374 was implemented.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.

• Brand Name: SAFESHEATH® II
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 24683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 24683
• Manufacturer Contact: ronnie greco ; 4875 palm harbor blvd.; palm harbor, FL 24683 ; 7279372511
• MDR Report Key: 21744720
• Report Number: 1035166-2025-00018
• Device Sequence Number: 19831821
• Product Code: DYB
• UDI-Device Identifier: 30891492002211
• UDI-Public: 30891492002211
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122094
• 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,Followup
• Report Date (Section B): 05/01/2025

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: DOR14006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/10/2024
• 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