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

Model Number	SS11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported when explanting the right ventricular (rv) lead, in attempt to gain access to place another lead, a perforation of the superior vena cava (svc) occurred.The patient was immediately sent in for cardiac surgery, however attempts to stabilize patient were unsuccessful and the patient did not survive.Additional information reported the physician indicated the perforation was likely due to the introducer used to gain venous access.It was further reported as unknown, as to whether the dilator or sheath caused the perforation.No reported issue with the dilator or sheath.The dilator and sheath will not be returned, as they were thrown away after the case.No additional information available.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported when explanting the right ventricular (rv) lead, in attempt to gain access to place another lead, a perforation of the superior vena cava (svc) occurred.The patient was immediately sent in for cardiac surgery, however attempts to stabilize patient were unsuccessful and the patient did not survive.Additional information reported the physician indicated the perforation was likely due to the introducer used to gain venous access.It was further reported as unknown, as to whether the dilator or sheath caused the perforation.No reported issue with the dilator or sheath.The dilator and sheath will not be returned, as they were thrown away after the case.No additional information available.
Additional Manufacturer Narrative
The device was used in treatment.The device was not returned for evaluation, as it was discarded.There was no specific malfunction reported by the user.The device history records were reviewed to confirm that the device passed all applicable in process and final inspections before shipping to the customer.There was no product performance issue reported.No further follow-up is required.Based on the investigation, a capa is not required.The event will be re-evaluated if additional information becomes available.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 INTRODUCER SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 13584641
• Report Number: 1035166-2022-00028
• Device Sequence Number: 4369105
• Product Code: DYB
• UDI-Device Identifier: 30891492002297
• UDI-Public: 30891492002297
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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 Expiration Date: 08/01/2023
• Device Model Number: SS11
• Device Catalogue Number: SS11
• Device Lot Number: DP08956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female