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

Model Number	SSCL9
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This sscl9 was used in treatment.The device was discarded; therefore, it was not returned for analysis.There was no device performance failure reported by the user.This event is related to patient condition.No further investigation is required.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 a post operative check on the day of implant the patient reported feeling some pain their upper left chest.A chest x-ray was performed and the physician suspected that the distal end of the extravascular (ev) lead may have entered the left pleura.Five days later some device site pain was still present, but the "lung pain" had eased.The patient will continue to be monitored, and the ev lead remains in use.No further patient complications have been reported as a result of this event.27/mar/2025 there was no device performance failure reported by the user, for the sscl9.The device will not be returned as it was discarded.Submission for administrative purposes.

• Brand Name: SAFESHEATH® LL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: ron greco ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 21709944
• Report Number: 1035166-2025-00014
• Device Sequence Number: 9942002
• Product Code: DYB
• UDI-Device Identifier: 10885672009899
• UDI-Public: 10885672009899
• 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): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SSCL9
• Device Catalogue Number: SSCL9
• Device Lot Number: S9197614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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