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

Model Number	TG0704509
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Customer says the dilator did not stay inside of the catheter (they also said it does not stay clicked when the dilator is pushed into the catheter and if it does, then it is difficult to remove the dilator from inside the catheter).When the dilator did slide out of the catheter, the catheter caused damage on the vessel and they had to repair it with open surgery.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: the device was used in treatment.One 7f tour guide steerable introducer sheath was received back from the customer with the dilator.There were no other accessories.Traces of blood were found on and inside the sheath and dilator.According to the event description summary, the dilator did not click into and stay attached to the sheath.Upon evaluation, it was found that the hub cap rim of the sheath where the dilator locks into looked normal with no obvious signs damage.The hub of the dilator looked normal with no obvious signs damage in comparison.The dilator snapped onto the sheath hub without any issues and fit snug and securely onto the hub and did not move when lightly pulled.Returned device analysis revealed the sheath and dilator were within manufacturing specifications.When tested here at oscor, the dilator passed fully and smoothly through the sheath and the hub of the dilator snapped onto the sheath hub without any issues.The dilator fit snug and securely onto the hub and did not move when lightly pulled.According to the device history record, the sheath and dilator passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.No manufacturing defects were found.Per procedure thermoplastic over molding of parts: sample size: 100%.While parts are in process: perform a visual inspection to verify the parts meet applicable cosmetic criteria (e.G.Flash, short shots, gate blush, fm, etc.).Per procedure destino dilator in-process and final inspection: sample size: 5 first and 5 last good shots inspect 100%.Visual inspection: hub to be round and smooth, no irregularities inside.At 12-18" distance, hub shape should be as per drawing, flash <0.75 mm or pinch should not exceed 0.2 mm (use profile projector if needed).Measure id of dilator hub by inserting appropriate pin gauge through hub.Per instructions for use (ifu): place dilator inside the sheath and snap on both hubs together.Thread the dilator/sheath assembly over the guidewire, using a slight twisting motion.Note: 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.Corrective actions initiated to investigate and mitigate the reoccurrence of this issue, the corrective action is based on the fact that there are further cases with the same issue reported.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: 15899220
• Report Number: 1035166-2022-00122
• Device Sequence Number: 5122908
• Product Code: DYB
• UDI-Device Identifier: 00850232006055
• UDI-Public: 00850232006055
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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 Expiration Date: 02/01/2025
• Device Model Number: TG0704509
• Device Catalogue Number: TG0704509
• Device Lot Number: DP-15131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown