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

Model Number	990061-055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Chronic Obstructive Pulmonary Disease (COPD) (2237); Coma (2417); Pericardial Effusion (3271)
Date of Event	04/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device used in treatment and not returned for analysis (discarded).There was no performance related failure reported by the user.However, the device history records are in place to mitigate that the devices passed all applicable in process and final inspections before shipping to the customer.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.
Event or Problem Description
It was reported that during a cryo ablation procedure, the patient had a drop in blood pressure.An echocardiogram was performed and a cardiac effusion was observed.A pericardiocentesis was performed.The case was completed with cryo.It was further indicated that three days following the procedure, the patient died due to patient comorbidities (pericardial effusion and hypotension).Date of death is (b)(6) 2020.No additional information is available.No product malfunction reported.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b4, b5, g4, g7, h2, h6, and h10: h2 additional information: b5, and h6.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
On (b)(6)2020 additional information reported the patient underwent cryoablation of the pulmonary veins for the treatment of atrial fibrillation, refractory to medical therapy.When placing the device on the septal pulmonary veins, the same is dislocated in the right atrium.It was therefore repositioned in left atrium, through the previous transseptal puncture site by means of a guide.Following this maneuver it was determined cardiac tamponade, resolved with percutaneous drainage.The patient was then transferred to intensive care; hemodynamics was restored following percutaneous drainage, and respiratory arrest treated with mechanic ventilation.For 22 days after procedure, the patient remained in an irreversible coma and died on(b)(6)2020.The sequence of events was attributed to the patient's fragility and comorbidities.

• Brand Name: ARRIVE BRAIDED TRANSSEPTAL SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor, fl
• MDR Report Key: 10298618
• Report Number: 1035166-2020-00046
• Device Sequence Number: 3853533
• Product Code: DYB
• UDI-Device Identifier: 00643169530584
• UDI-Public: 00643169530584
• Combination Product (Y/N): N
• 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): 08/28/2020

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: 12/01/2020
• Device Model Number: 990061-055
• Device Catalogue Number: 990061-055
• Device Lot Number: C1-13923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/01/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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: Required Intervention