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

Model Number	SS9
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	03/25/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that during an implant procedure there were difficulties in using the first introducer (13cm) due to patient anatomy.A different longer introducer was used (23cm) and able to pass the subclavian angle.The implant procedure was completed successfully.After the implant the patient had symptoms and was taken to cardiac surgery where a subclavian vein laceration was discovered.The laceration was stitched up.The patient died following the procedure.The device was discarded.Patient death was on (b)(6) 2023.Cause of the patient death is unknown.Other event related to the issue reported: 1035166-2023-00049 addresses the 23cm introducer (same patient).
Additional Manufacturer Narrative
There was no product performance issue reported.The procedure was completed; however, due to patient complications the patient died.No further investigation 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.
Additional Manufacturer Narrative
Corrections: b3, b4 information missing from initial submission.There was no reported device failure in this event.The event is related to the patient's existing condition, which during an implant procedure there were difficulties in using the first introducer (13cm) due to patient anatomy.After the implant procedure was completed, the patient had symptoms and was taken to cardiac surgery where a subclavian vein laceration was discovered.The laceration was stitched up; however, the patient died following the procedure.Patient death was on (b)(6) 2023.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 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 16855063
• Report Number: 1035166-2023-00047
• Device Sequence Number: 6770815
• Product Code: DYB
• UDI-Device Identifier: 30891492002259
• UDI-Public: 30891492002259
• 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): 10/25/2023

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: SS9
• Device Catalogue Number: SS9
• Device Lot Number: DP-17212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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; Death; Life Threatening; Hospitalization
• Patient Sex: Unknown