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 Code	Pericardial Effusion (3271)
Date of Event	03/10/2021
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 during surgery patient experienced pericardial effusion.No treatment required to treat the pericardial effusion.The case was aborted and procedure scheduled for another time.There was no issue with arrive guiding sheath reported.No other adverse event reported.No additional information available.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b3, b4, g3, g6, h2, h6 and h10 device used in treatment and not returned for analysis, as device was discarded by the user facility.There was no device performance related failure reported by the user.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No further investigation is required.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 inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report isbased 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 1816
• MDR Report Key: 11651550
• Report Number: 1035166-2021-00040
• Device Sequence Number: 19672156
• 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: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 04/01/2023
• Device Model Number: 990061-070
• Device Catalogue Number: 990061-070
• Device Lot Number: C1-19361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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