MAUDE Adverse Event Report: OSCOR INC. DIREX¿ STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	M004DS200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
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.
Event or Problem Description
It was reported, lab staff notified ep rep that direx steerable sheath hemostasis value was leaking during procedure.Physician replaced sheath with another direx which resolved the issue.The lot number is unknown and the device was disposed of on site.No patient health consequences or impact was reported.No additional information is available.
Additional Manufacturer Narrative
The device was used in treatment.One direx 8.5f steerable introducer sheath was received back from the customer with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.There was a visible hole in the hemostatic valve.During the decontamination process, the sheath leaked from the hemostatic valve immediately when water was flushed through the sideport tubing assembly with a syringe.Upon evaluation of the sheath under a microscope, it was found that the insertion point of the device used in conjunction with the sheath was identified to be considerably off center of the helical cuts, which created a hole in the hemostatic valve.Returned device analysis revealed the sheath was within manufacturing specifications.There was a hole in the hemostasis valve and the sheath leaked immediately from the valve when tested with a syringe.The potential cause of the hole/leak could be if the dilator (or other device) was not inserted through the center of the valve as per instructions for use.Since the lot number is unknown, the device history records cannot be reviewed to see if there's any related issues or anomalies.However, inspection procedures require any oscor product to pass all in-process and qa final inspections before shipping to the customer.No manufacturing defects were found.Per procedure destino steerable guiding sheath in-process and final inspection: leak test: sample size: 100% perform leak test according to procedure.The leak test is performed by manufacturing personnel and is observed by quality assurance personnel at an aql level.The instructions for use (ifu) informs the user: wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.Place dilator inside the sheath and lock both hubs together.Thread the dilator/sheath assembly over the guidewire, using a slight twisting motion.Note: any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing of the seal and leakage.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: DIREX¿ 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 13366030
• Report Number: 1035166-2022-00016
• Device Sequence Number: 5354284
• Product Code: DYB
• UDI-Device Identifier: 08714729858928
• UDI-Public: 08714729858928
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120459
• 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,Followup
• Report Date (Section B): 06/08/2022

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 Model Number: M004DS200
• Device Catalogue Number: M004DS200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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