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	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Based on the information provided by the supporting documentation, "the physician noted the dilator was difficult to pass through the 6f safesheath but managed with a little more force than usually required.After the procedure the physician cracked the hub of the discarded sheath out of interest and noted it was difficult to split".No harm to patient.A review of the manufacturing processes indicates the production operators are instructed to 100% visually inspect for any obvious defect prior to shipment.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.Per ifu; flush sheath with 5cc of saline immediately before peeling sheath away to minimize back bleeding.Withdraw sheath and valve over the lead or catheter and from the vessel, while keeping the lead in place.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.Capa-05374 was initiated to further investigate this issue.No product was provided for analysis.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
The physician stated the dilator was difficult to pass through the 6f safesheath but managed with a little more force than usually required.When breaking at the hub he noted it took a little more effort than it used to.After the procedure the physician cracked the hub of the discarded sheath out of interest and noted it was difficult to split.No harm to patient.The type of procedure was an implant of pulse generator and leads.It appears there was a delay in the procedure in order to use additional products, however it is unknown if this was greater than 30 minutes.Replacement safesheath lot was from the same lot as reported defective.Product discarded.

• 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: 21741711
• Report Number: 1035166-2025-00017
• Device Sequence Number: 15703829
• 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: 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): 04/01/2025

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: S9312090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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