MAUDE Adverse Event Report: OSCOR.INC SENOVO BI-FLEX STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	454952
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/31/2023
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 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
The patient suffered from a pericardial effusion with low blood pressure, and dizziness after transseptal puncture.The patient was hospitalized.For diagnostics echocardiography was done.Successful pericaridal puncture with 600 ml aspiration was done.No device malfunction  reported.No additional information is available.
Additional Manufacturer Narrative
No product was provided for analysis.There was no device malfunction reported.However, there was adverse event with patient reported.Cuse of the adverse event may have been related to patient anatomy as patient has a thick cardiac septum and it was difficult to probing the left atrium with a needle.Ablation procedure was completed successfully.Post-procedural echography showed adverse side effects.The lot number was not provided by the customer; therefore, the device history record could not be reviewed, however, inspection procedures require any oscor product to pass all in-process and qa final inspection before shipping to the customer.No product was returned to oscor and no known device malfunction was reported.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is unconfirmed - no problem detected as no device malfunction was reported.No corrections or corrective actions will be taken.No device was returned for analysis and there was no device malfunction reported.Review of the manufacturing records did not reveal any discrepancies that would have contributed to this event.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: SENOVO BI-FLEX STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR.INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR.INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 17669830
• Report Number: 1035166-2023-00094
• Device Sequence Number: 15225779
• Product Code: DYB
• UDI-Device Identifier: 00885672009915
• UDI-Public: 00885672009915
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151951
• 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): 10/20/2023

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 Model Number: 454952
• Device Catalogue Number: 454952
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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