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

Model Number	TG0654509
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2022
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.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
The handle is outside of the patient and the complaint is about the dilator-to-guide connection outside of the patient's body.The dilator does not connect to the guide.There is nothing that it can stay connected to.The dilator is completely loose and free-riding and immediately upon touching anything at the end it will slide inside of the guide.The patient has not and will not receive treatment.Event was not resolved.It is unknown if there were any patient symptoms or complications associated with this event.Additional information has been requested.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, the investigation was focused on product documentation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.However, the following controls are in place to mitigate the reported product issue.Capa was opened to investigate the root cause and implement corrective action to prevent recurrence of this issue.Per procedure (thermoplastic overmolding 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 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 actions initiated to investigate and mitigate the reoccurrence of this issue.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 ; 7279352511
• MDR Report Key: 16368229
• Report Number: 1035166-2023-00013
• Device Sequence Number: 6748617
• Product Code: DYB
• UDI-Device Identifier: 00850232006017
• UDI-Public: 00850232006017
• 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): 07/07/2023

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: 02/01/2025
• Device Model Number: TG0654509
• Device Catalogue Number: TG0654509
• Device Lot Number: DP-15135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• 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