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

Model Number	D141101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
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 the pull wire broke during procedure.Changed to a new sheath (no delay in surgery) and procedure was successfully completed.Additionally, it was reported a small amount of fluid was leaking at the end of the screw mechanism, where the dilator is screwed in.No patient consequences reported.No additional information is available.
Additional Manufacturer Narrative
The device was used in treatment.One 13.5f guidestar steerable guiding sheath was received with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.According to the event description summary, the pullwire broke during procedure and the sheath leaked at the end where dilator is screwed in.The sheath was x-rayed and no breaks in the pullwire were found and the hypotubes were intact.Also, the sheath deflected normally as intended.The valve was viewed under a 10x microscope and looked normal with no anomalies.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 device was occluded at the distal tip and pressurized to 38kpa and held at this pressure for 30 seconds and no leakage was observed from the hemostatic valve.The sheath was further pressurized beyond 300kpa and no leakage was observed from the stopcock, sideport or through the handle.The threaded end of the handle (proximal end) that the dilator lock nut screws onto looked normal with no anomalies.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed the sheath is within manufacturing specifications.According to the event description summary, the pullwire broke during procedure and the sheath leaked at the proximal end where dilator is screwed in.X-rays revealed that there was no breakage in the pullwire.When tested, the sheath deflected as intended.The sheath didn't leak when tested manually and when using the iso leakage method.The proximal end of the handle looked normal with no anomalies.According to the device history records, the introducer 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.The reason for return could not be confirmed.Per manufacturing procedure destino twist steerable guiding sheath handle assembly: sample size: 100%.Deflect the handle assembly using the deflection knob to assure that the completed product deflects as required.Per qa procedure destino steerable guiding sheath in-process and final inspection: deflection test is performed 100% by manufacturing personnel per procedure, and inspected by quality personnel at an aql level (sample size: ansi z 1.4, gen level i, normal, aql 1.5.For unidirectional models, verify the deflection knob is set to 0.Place the deflection section of the device on the applicable template as shown in figures below and deflect the device until the curve falls within the applicable deflection template.Verify the device can deflect to 170° (nominal 180° - 10°) on half the template.Sample size: ansi z 1.4, gen level i, normal, aql 1.5 normal perform leak test according to procedure based on available leak tester.The leak test is performed by manufacturing personnel at 100% and is observed by quality assurance personnel at aql level ansi z 1.4, gen level i, normal, aql 1.5 normal.The instructions for use (ifu) in forms the user: preparing steerable sheath for insertion.Verify deflecting and straightening of the distal section of the steerable sheath using the handle of the sheath.Refer to deflecting and straightening the steerable sheath" for instructions.General use of the steerable sheath.Do not force the steerable sheath assembly if significant resistance is encountered during the insertion or passage.If resistance is encountered, determine the cause and correct before continuing the procedure.The steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Aspiration and flushing of the sheath should be performed frequently to help minimize the potential for air embolism.For injecting or aspirating through the sheath, use the sideport only with stopcock.Prior to infusion, remove all air using the sideport.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: GUIDESTAR¿ 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 13684771
• Report Number: 1035166-2022-00036
• Device Sequence Number: 1905611
• Product Code: DYB
• UDI-Device Identifier: 00885672009496
• UDI-Public: 00885672009496
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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 Expiration Date: 06/01/2023
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-19340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2020
• 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