MAUDE Adverse Event Report: OSCOR INC. APTUS ENDOSYSTEMS TOURGUIDE¿ STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	TG0655509
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The physicians were using a 6.5f tourguide in a lead interventional radiology (ir) case and reported the sheath was leaking at the backend wire port.Another 6.5f tourguide from same lot number, was opened and the green cap fell off.Patient received treatment.Reported event was resolved as case was completed.It was reported no patient symptoms or complications associated with this event.Reference report # 1035166-2023-00006.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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.
Additional Manufacturer Narrative
One 6.5f tourguide steerable guiding sheath was returned from the customer without the dilators.There were no other accessories.Blood was found on and inside the sheath; this evaluation is focused on the sheath where the hub cap became detached from the handle.Upon receipt of the sheath, it was found that the green hub cap was very loosely attached to the hub.During the beginning of the decontamination process, the hub cap easily fell off of the hub.The photos below show the cap and hub under magnification.The cap snap feature which is intended to serve as a mechanical joint holding the cap in place was found to be properly formed.Slight out of roundness was observed but was not found to have any effect on the snap feature structural integrity.Light signs of discoloration were evidenced on the internal face of the snap cap, indicating prior contact with cyanoacrylate adhesive.Although presence of glue was not specifically evidenced, the discoloration marks are indicative of prior presence of the adhesive.The adhesive is added to further strengthen the bond.No specific manufacturing defects were identified on the device analysis, after review and inspection.As established in et200053-r, the mechanical fastening joint obtained with the snap feature built into the sheath cap is capable of withstanding a longitudinal force of 15 n or greater, as required by iso 11070.The most probable cause of the reported device failure is that a force exceeding 15n was applied on the cap, or a lateral jerking (shear) motion was applied to the device in which cases a slight deformation (ovality) on the thinner wall of the cap, may facilitate disengagement when under tension, through internal pressure buildup or during device removal and / or withdrawal.No manufacturing rejects or anomalies of this type were recorded in the device history record.The introducer sheath passed all in-process and qa final inspection steps before shipping to the customer, including visual, dimensional and mechanical tests.No manufacturing defects were found.Per procedure non-peelable sheath final assembly: ·glue is placed using a glue dispensing tip below the seal around the outer rim of the sheath hub.The bonded cap of appropriate color is seated properly over the hub and is secured with a sheath assembly fixture.The sheath is allowed to remain in the fixture for at least 2 minutes after securing the last sheath in the fixture.After it is removed from the fixture, ensure that there is no excess adhesive.·after the fixture is removed, each sheath is laid flat on the table for a minimum of 15 minutes before proceeding.Sheath assemblies must remain undisturbed for a minimum of 15 minutes.·bonded caps are visually inspected after curing.Gap between the bonded cap and the hub should not exceed 0.020".Sheath should be free of damages and defects.Per procedure destino steerable guiding sheath in-process and final inspection: cap and seal are inspected and the results are registered on the inspection form.Sample size: ansi z 1.4, gen level i, normal, aql 1.5 normal leak test is performed 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.The instructions for use (ifu) informs the user: use the sideport, located at the handle, to inject contrast solution or flush the steerable sheath.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.The samples are dispositioned per the applicable customer agreement as per procedure pro-001019.In conclusion, based on the information available at this time it cannot be confirmed that the product failed to meet requirements.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: APTUS ENDOSYSTEMS TOURGUIDE¿ 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 ; 7279352511
• MDR Report Key: 16225639
• Report Number: 1035166-2023-00007
• Device Sequence Number: 14770442
• Product Code: DYB
• UDI-Device Identifier: 00850232006031
• UDI-Public: 00850232006031
• 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): 02/27/2024

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: 08/01/2025
• Device Model Number: TG0655509
• Device Catalogue Number: TG0655509
• Device Lot Number: DP-16552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/20/2024
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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