MAUDE Adverse Event Report: OSCOR INC. BAYLIS MED TECH PASSPORT¿ STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	PSS0705509TD
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned to oscor inc.For evaluation; however, a picture was provided, and a complaint notification was received.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.A review of the manufacturing processes indicates the production operators are instructed to 100% visually inspect for any obvious defect prior to shipment.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.Based on the information available at this time it cannot be confirmed that the product failed to meet requirements.The complaint is non-verifiable, as the product was not returned for evaluation.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.
Event or Problem Description
It was reported fluid, red in color, was leaking from hemostatic valve, located on the proximal portion of the handle.Immediately thereafter insertion, in-vivo leakage ranging from low-flow to moderate flow of fluid red in color from the device hemostatic valve occurred otw, otw&c during static and dynamic conditions in line with the instructions for use (ifu).It was reported all preprocedural and intraprocedural steps were taken per the ifu.A second device of the same model and lot, was used but the occurrence repeated itself.Doctor used an ansel fixed curved catheter and procedure was completed.Ther was no delay in the procedure and no patient harm was reported.

• Brand Name: BAYLIS MED TECH PASSPORT¿ STEERABLE 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: 19277988
• Report Number: 1035166-2024-00051
• Device Sequence Number: 12679859
• Product Code: DYB
• UDI-Device Identifier: 00885672012595
• UDI-Public: 00885672012595
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 09/01/2026
• Device Model Number: PSS0705509TD
• Device Catalogue Number: PSS0705509TD
• Device Lot Number: DP-20369
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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