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

Model Number	M004DS50S0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used in treatment.One 12f direx steerable introducer sheath was returned from the customer without the dilator.Blood was found on and inside the sheath.Upon evaluation of the returned product, it was found the hemostatic valve was torn.No leakage was found from the valve when manually leak tested at the site where the sideport tubing and stopcock attaches to the hub.The introducer was then tested using the iso 11070 liquid leakage test method.The device was connected at the distal tip and pressurized to 38kpa and then examined for liquid leakage.The device passed this part of the leak test.The leak tester was then increased to pressurize the device up to 300kpa, but started leaking from the hemostatic valve once it reached approximately 87kpa.Multiple attempts were made to obtain clarification of the event from the customer.As of today, no information is available.Device history records were reviewed to confirm the device passed all applicable in-process and final inspections.Per qa procedure destino steerable guiding sheath in-process and final inspection: perform leak test according to procedure based on available leak tester.The leak test is performed by manufacturing personnel and is observed by quality assurance personnel.The sample size for the leak test is 100% by manufacturing and a sampling plan by qa as per ansi z1.4 aql 0.65, general level l, normal.Per instructions for use (ifu): 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.
Event or Problem Description
It was reported patient was unharmed and procedure was completed.The faulty device was back.During the device analysis it was found the hemostatic valve was torn and leaking.No additional information is available.

• Brand Name: DIREX STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 12421556
• Report Number: 1035166-2021-00095
• Device Sequence Number: 19991988
• Product Code: DYB
• UDI-Device Identifier: 08714729858997
• UDI-Public: 08714729858997
• 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
• Report Date (Section B): 09/03/2021

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: 09/01/2022
• Device Model Number: M004DS50S0
• Device Catalogue Number: M004DS50S0
• Device Lot Number: C8-17848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1