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

Model Number	990061-070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Blood Loss (2597); Pericardial Effusion (3271)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our investigation is still in progress ,follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that after cryo ablation procedure patient had low blood pressure.The physician concluded the patient had a pericardial effusion resulting from cardiac tamponade.The reason for and time of the tamponade is unknown.A pericardiocentesis was performed, successfully increasing the blood pressure, but it did not stop the bleeding.The patient was transferred to cardiac surgery to stop the bleeding and close the tamponade; the bleeding was stopped successfully but the patient became hemodynamically unstable.The patient was transferred to the intensive care unit for monitoring and hemodialysis was performed.The patient passed away during the night.Date of death is (b)(6) 2019.Cause of death is cardiac tamponade lead to pericardial effusion.The reason and the time of the tamponade is unknown.No additional information available.No product malfunction reported.
Additional Manufacturer Narrative
The device was used for treatment.There was no product performance issue reported.The device was not returned for evaluation, therefore, the clinical observation could not be confirmed.The investigation will focus on the documentation review.The device history records were reviewed to confirm that the devices passed all applicable in process and final inspections based on the investigation, a capa is not required as there was no issue reported for the device performance or quality.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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: ARRIVE¿ BRAIDED TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 9452435
• Report Number: 1035166-2019-00118
• Device Sequence Number: 14104795
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 04/01/2022
• Device Model Number: 990061-070
• Device Catalogue Number: 990061-070
• Device Lot Number: C1-16799
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention