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

Model Number 990061-070

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Cardiac Tamponade (2226)

Event Date 07/13/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 321436368
• Report Number: 1035166-2023-00085
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169530591
• UDI-Public: 00643169530591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 990061-070
• Device Catalogue Number: 990061-070
• Device Lot Number: DP-18999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Life Threatening