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

Model Number	990091-070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	04/08/2021
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.
Event or Problem Description
It was reported that following a successful cryo ablation procedure, the patient had low blood pressure and began to decompensate.A thoracic echography was performed and a cardiac tamponade was observed.Surgical intervention took place, a small hole (perforation) was detected in the intersection svc and ra.The tamponade was drained and perforation repaired, patient is in very good condition.There was no issue reported with the arrive guiding sheath.No extended hospitalization required and no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The device was used in treatment and not returned for analysis as device could not recovered 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 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: 11825641
• Report Number: 1035166-2021-00047
• Device Sequence Number: 14563770
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 990091-070
• Device Catalogue Number: 990091-070
• Device Lot Number: C1-19365
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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: Required Intervention