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	Cardiac Tamponade (2226)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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 have not 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
It was reported, by hcps, that immediately following a cardiac ablation procedure, fluid was observed via ultrasound, indicating a cardiac tamponade.The patient was under general anesthesia at the time.An infusion was performed to extract the fluid.The patient's outcome was reported as alive, with injury (cardiac tamponade).The tamponade was observed after the physician took the sheath and the ballon out, so the procedure was already completed.They did pericardial infusion to remove the fluid that was found, and the patient recovered completely.The physician wasn't 100% sure but they assume that the incident occurred during the transeptal puncture.For transeptal we used our arrive sheath.No issue with arrive sheath reported.The arrive sheath is not available to evaluate, as they discarded it.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b4,g3,g6,h2,h6 and h11.There was no device malfunction reported with arrive sheath.Patient had cardiac tamponade repotted at the end of the procedure.Physician did pericardial infusion to remove the fluid that was found and the patient recovered completely.No product was provided for analysis as it was discarded by user facility.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No product was returned to integer.For evaluation, however, a complaint notification was provided.Without the return of the actual device in question for evaluation, integer is unable to determine the exact cause of this incident.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.No corrections will be taken at this time as no allegations made against the device.This complaint is non-verifiable.Integer.Inc/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.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: ron greco ; 4875 palm harbor blvd.; palm harbor, FL 34683
• MDR Report Key: 21988077
• Report Number: 1035166-2025-00030
• Device Sequence Number: 15591796
• Product Code: DYB
• UDI-Device Identifier: 00643169530591
• UDI-Public: 00643169530591
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 06/01/2026
• Device Model Number: 990061-070
• Device Catalogue Number: 990061-070
• Device Lot Number: DP-19570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown