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	06/27/2024
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
Hemostatic tear-away introducer system with infusion side port.The item is used to implant pacemaker leads.Once the leads are in position the sheath is split open and removed.It has been observed on several occasions that when the sheath is split, debris is lost and has been falling into the pacemaker pocket.The hemostatic valve should split cleanly.The issue appears to only be affecting 6f sheaths.Event occurred with four (4) patients.Items took out of circulation.Sourcing replacement on-going.Product discarded.
Event or Problem Description
Related records for additional patient's: (b)(4).
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, b5, g3, g6, h2, h6 & h11.No product was provided for analysis as product was discarded by customer.The customer stated the sheath split, debris is lost and has been falling into the pacemaker pocket.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.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: 19721670
• Report Number: 1035166-2024-00081
• Device Sequence Number: 8148104
• 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,Followup
• Report Date (Section B): 09/13/2024

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: DP20955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/13/2024
• 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