MAUDE Adverse Event Report: OSCOR.INC BAYLIS MED TECH PASSPORT STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	PSS0706509
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a mesenteric intervention procedure, a surgeon placed a passport steerable sheath over a stiff wire from left axillary percutaneous access into the descending thoracic aorta.Shortly after placement, the valve of the sheath began leaking heavily.Due to the challenging location, getting an appropriately sized replacement sheath in place took several minutes, resulting in approximately 250-300cc of blood loss.The surgeon attempted to stop the bleeding by replacing the dilator, but it did not pass easily, and the bleeding continued.The procedure was completed successfully by replaying the sheath with a similar sized sheath.Please note the importer's report number is 9710452-2024-00005.
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 (1) steerable sheath 7f ud9mm s65cm d83cm was returned from the customer under rga#(b)(4).There were no other accessories.Blood was found on and inside the catheter.According to the event description summary, shortly after placing the passport sheath into the aorta, the valve of the sheath started leaking precipitously.During the decontamination process, the sheath leaked immediately from under the handle when water was flushed through the sideport tubing assembly with a syringe.It should be noted that the sheath did not leak from the hemostatic valve as stated in the event description.The valve looked normal and intact as per the drawing.An x-ray under the handle revealed that the braiding under the sheath shaft broke apart.When the handle was removed from the sheath, the exact point of leakage was revealed right under the junction between the hub and sheath shaft.This emphasized the possibility of the device being subjected to stresses beyond its capabilities during use out in the field.There was also damage done to the dilator tip likely from trying to force it into the sheath after the damage was done.Returned device analysis revealed the sheath was within manufacturing specifications.The sheath leaked under the handle due to shaft breakage.The most probable cause of failure is torquing of the handle while devices were placed in a deflected state while resistance was felt.Torquing of the device when resistance is present can cause the front catheter support bond to fail allowing the distal end of the shaft to rotate inside the handle.This torquing causes the shaft to break where the braid is terminated to extract the pullwire during shaft assembly.As per ifu, the user is cautioned not to deflect the sheath with dilator or with any other device inserted.It is believed that this device was subjected to stresses beyond its capabilities during use out in the field.No manufacturing rejects or anomalies of this type were recorded in the device history record.The steerable introducer sheath passed all in-process and qa final inspection steps before shipping to the customer, including visual, dimensional and mechanical tests.Per qa procedure leak test - introducer/destino with seal- electronic tester/prueba, 100% by manufacturing and a sampling plan as per ansi z1.4 aql 0.65, general level l, normal, verify according to the procedure that none of the parts mark red during the first test to ensure that there are no leaks.Visual inspection: under 10x magnification, for damages, cracks, and excess of glue.The instructions for use (ifu) informs the user: avoid subjecting the device to unusual stresses.Handle the steerable sheath with care at all times.Do not deflect the sheath with dilator or with the device inserted.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.When in the deflected position, the steerable guiding sheath should not be rotated while encountering resistance since that could severely damage the vessel, heart chamber, or anatomy of the patient.Corrections are not required because the investigation did not conclude that the product or process did not meet specification at the time of shipment.The investigation concluded that the product met specification at the time of shipment.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: BAYLIS MED TECH PASSPORT STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR.INC; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR.INC; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: ronnie greco ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 19844484
• Report Number: 1035166-2024-00085
• Device Sequence Number: 12679075
• Product Code: DYB
• UDI-Device Identifier: 00885672012564
• UDI-Public: 00885672012564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PSS0706509
• Device Catalogue Number: PSS0706509
• Device Lot Number: DP-20778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown