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 Code	Perforation (2001)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported that during a cryo ablation procedure, the sheath was inserted into the patient after the transeptal puncture was completed.It was difficult maneuvering the guide for the sheath and the introducer of the sheath perforated through the aorta.The procedure was aborted.The patients hospitalization was extended for the patient to undergo heart surgery.No further patient complications have been reported as a result of this event.Following a contrast by the introducer for difficulty in maneuvering the guide, visualization of the introducer in the aorta.Procedure immediately blocked.Patient with stable vital signs.Introducer and guide left in place and secured.The patient was transported by helicopter to the heart surgery of the (b)(6) hospital.The physician was performing transseptal with needle when issue occurred.The introducer was extracted in the cardiosurgery lab.The patient was discharged from the hospital in good condition.No alleged product use.
Event or Problem Description
It was reported that during a cryo ablation procedure, the sheath was inserted into the patient after the transeptal puncture was completed.It was difficult maneuvering the guide for the sheath and the introducer of the sheath perforated through the aorta.The procedure was aborted.The patients hospitalization was extended for the patient to undergo heart surgery.No further patient complications have been reported as a result of this event.Following a contrast by the introducer for difficulty in maneuvering the guide, visualization of the introducer in the aorta.Procedure immediately blocked.Patient with stable vital signs.Introducer and guide left in place and secured.The patient was transported by helicopter to the heart surgery of the (b)(6) hospital.The physician was performing transseptal with needle when issue occurred.The introducer was extracted in the cardiosurgery lab.The patient was discharged from the hospital in good condition.No alleged product use.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
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.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 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13005572
• Report Number: 1035166-2021-00154
• Device Sequence Number: 14684026
• Product Code: DYB
• UDI-Device Identifier: 00643169530584
• UDI-Public: 00643169530584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/04/2022

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: 12/01/2022
• Device Model Number: 990061-055
• Device Catalogue Number: 990061-055
• Device Lot Number: C1-18300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male