MAUDE Adverse Event Report: OSCOR INC. ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH; INTRODUCER, CATHETER

Model Number	990061-070
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device failure in this event.The event is related to the patient outcome after the procedure was completed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.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 following a completed cryo ablation procedure, the patient had difficulty recovering from deep sedation.A magnetic resonance imaging (mri) scan was performed and showed an acute thromboembolic stroke.The patient received thrombolysis. no further patient complications have been reported as a result of this event.Customer discarded the product.The patient was not under general anesthesia.Patient symptoms include neurologic stroke or cerebral vascular accident.This report is for administrative purposes only.

• Brand Name: ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 17573220
• Report Number: 1035166-2023-00085
• Device Sequence Number: 15704868
• Product Code: DYB
• UDI-Device Identifier: 00643169530591
• UDI-Public: 00643169530591
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101497
• 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): 08/18/2023

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 Expiration Date: 04/01/2026
• Device Model Number: 990061-070
• Device Catalogue Number: 990061-070
• Device Lot Number: DP-18999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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: Other; Hospitalization; Life Threatening
• Patient Sex: Unknown