MAUDE Adverse Event Report: OSCOR INC. GUIDESTAR¿ STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	D141103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported:: 1.During the case, after rf application around the lipv, change of the patient ekg, translating signs of heart attack or coronary spasms (uncertain reason) 2.Standardization of the ekg after 10 minutes.The ablation was finalized without another incident.3.Around 1h 30 later, patient presented stroke symptoms.4.Neurological symptoms have disappeared at the end of the day.Additional information: during the case, all devices have been used according to usage instructions: ablation at 15w during 45sec for anterior part and 15sec for the posterior part in total, patient received 4 rf application for a total of 3minutes of radiofrequency.Act measured at 365 during the case.An external shock was performed at the end of the case to restore sinus rhythm.Following the case, patient had additional exam: coronary angiography which appeared normal cerebral irm: lesion were found confirming the stroke diagnostic.Submitting for administrative purposes - adverse event.
Additional Manufacturer Narrative
There was no product malfunction reported; therefore, product was not returned.The complaint is related to the patient.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.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING 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: 17711481
• Report Number: 1035166-2023-00099
• Device Sequence Number: 15136200
• Product Code: DYB
• UDI-Device Identifier: 00885672010911
• UDI-Public: 00885672010911
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: 08/01/2025
• Device Model Number: D141103
• Device Catalogue Number: D141103
• Device Lot Number: DP-16674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown