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

Model Number	454952
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
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 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
It was reported at the end of the sheath blood came out of the valve.Till this point there was no needle or catheter in the sheath.The sheath was changed to a new senovo bi-flex steerable guiding sheath.Patient was not subjected to procedures which might have damaged the device.The event did not cause an adverse change in the patient's condition.The patient is 178cm (5'10") and has a weight of 84kg (186lbs).Additional information has been requested.
Event or Problem Description
The following additional information was reported, lot number is dp-16156.The issue occurred during the pvi procedure.No blood transfusion required, based upon the pictures, it appears not a lot of blood was loss.There was no catheter used, the sheath was changed directly after the blood flow.Procedure was completed successfully when the doctor changed the sheath.There was a 2-minute delay to change the sheath out.
Additional Manufacturer Narrative
The device was used in treatment.One 8.5f senovo bi-flex steerable guiding sheath was returned from the customer without the dilator.There were no other accessories.Blood was found on and inside the sheath.According to the event description summary, blood came out of the valve.Upon evaluation of the returned sheath, it was observed that the hemostatic valve was torn.The sheath was manually leak tested with the syringe connected to the stopcock and the tip occluded.The sheath did not exhibit leakage when tested using this method.The sheath was then tested using the iso 11070 for liquid leakage test method.The specification for the valve is 38kpa.The device was occluded at the distal tip and pressurized to approximately 25kpa when the hemostatic valve started to leak from the tear.Returned device analysis revealed the sheath was within manufacturing specifications.There was a tear in the hemostatic valve that caused the sheath to leak and fail the iso leak test.The sheaths are leak tested 100% by manufacturing and observed by qa at an aql level in-process, prior to shipping to the customer.The potential cause of the tear/leak could be if the dilator (or other device) was not inserted through the center of the valve as per instructions for use (ifu).According to the device history record, the sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional, mechanical and leak testing.No manufacturing defects were found.Per manufacturing procedure non-peelable sheath final assembly assembling the cap and seal visually inspect seals 100% before use.Carefully inspect seals to ensure that the helical center cut is present before assembly.Do not pull, bend or separate seals during inspection.If the seal is not properly cut, reject the seal and do not use for assembly.Notify the appropriate manufacturing supervisor before proceeding.Per procedure destino steerable guiding sheath in-process and final inspection: the leak test is performed according to procedure based on available leak tester.The leak test is performed by manufacturing personnel 100% and is observed by quality assurance personnel at an aql level.No further follow-up is required.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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
• MDR Report Key: 16777174
• Report Number: 1035166-2023-00053
• Device Sequence Number: 17857243
• Product Code: DYB
• UDI-Device Identifier: 00885672009915
• UDI-Public: 00885672009915
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: 454952
• Device Catalogue Number: 454952
• Device Lot Number: DP-16156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Patient Weight: 86 KG