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

Model Number	TG0704509
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported this the tourguide dilator does not attach into the guide hub.The dilator is loose inside the guide.No known patient harm reported.Additional information has been requested.
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
No product was provided for analysis.Procedure completed successfully with different device.There was no adverse event with the patient.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.No product was returned to oscor inc.For evaluation; however, a complaint notification was provided.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.  at this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.Per qa 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.The instructions for use (ifu) informs the user: 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 action initiated to prevent the re occurrence of this issue.Additionally, the risk remains acceptable, and no new failure mode identified.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: 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 ; 7279372511
• MDR Report Key: 16598705
• Report Number: 1035166-2023-00041
• Device Sequence Number: 11868828
• Product Code: DYB
• UDI-Device Identifier: 00850232006055
• UDI-Public: 00850232006055
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 11/01/2025
• Device Model Number: TG0704509
• Device Catalogue Number: TG0704509
• Device Lot Number: DP-17425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2022
• 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