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

Model Number	M004DS300
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 that: at the uniklinik regensburg we had two direx sheaths with malfunctions.The hemostatic seal of the first sheath was broken and therefore the dilator could not be advanced into the sheath and was therefore exchanged.The second sheath had a broken steering and only one side of the curve was operable this resulted in another sheath exchange.The third one worked without any further issues and the case was completed.Both sheaths are from the same lot.It was reported no known impact or consequence to patient.Additional information has been requested, including the event date.
Additional Manufacturer Narrative
H2 correction: h6 device code 1250.The device was used in treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per 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.This procedure is performed on 100% of the sheaths.The instructions for use (ifu) informs the user: adverse effects potential adverse effects related to the use of the steerable sheath include but are not limited to valve damage.In addition, deliver the device through the sheath hemostatic valve following its own instructions for use.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
• MDR Report Key: 9306792
• Report Number: 1035166-2019-00095
• Device Sequence Number: 19445147
• Product Code: DYB
• UDI-Device Identifier: 08714729858942
• UDI-Public: 08714729858942
• 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
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 04/01/2022
• Device Model Number: M004DS300
• Device Catalogue Number: M004DS300
• Device Lot Number: C8-17001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1