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

Model Number	TG0855517
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was provided for analysis, nor were any pictures provided by the customer.Its unclear what the user meant by the sheath folded in situ.Multiple attempts were made to obtain information related to this case; however, no information was provided by customer.Procedure was not continued due to unsatisfactory results of the nephogram showing a very poor-quality diffusion, unrelated to the folding.No adverse event with patient reported.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 of 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.No corrections or corrective actions will be taken.Device was not returned for analysis and review of the manufacturing documents did not reveal any discrepancies that would have contributed to this event.This complaint is non-verifiable.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 customer stated a 62-year-old patient treated for left renal artery recanalization.During the surgical procedure, the sheath folded in situ (in the original place).Difficulties in performing the surgical procedure.Its unclear what the user meant by the sheath folded in situ.Multiple attempts were made to obtain information related to this case; however, no information was provided by customer.Procedure was not continued due to unsatisfactory results of the nephogram showing a very poor-quality diffusion, unrelated to the folding.No adverse event with patient reported.

• 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: 19500156
• Report Number: 1035166-2024-00067
• Device Sequence Number: 6812100
• Product Code: DYB
• UDI-Device Identifier: 00850232006116
• UDI-Public: 00850232006116
• 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
• Report Date (Section B): 06/10/2024

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 Model Number: TG0855517
• Device Catalogue Number: TG0855517
• Device Lot Number: DP-21570
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2024
• 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 Age: 62 YR
• Patient Sex: Unknown