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

Model Number	TG0654509
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during the procedure there was a leak at the stopcock.The product is still at the hospital, if needed it can be returned otherwise it will be destroyed.The patient received treatment on (b)(6) 2024.Patient status at time of this report alive - no injury.The issue was resolved by using another tourguide.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report 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
The following sections were updated in follow-up 1.B4, g3, g6, h2, h6 & h11.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.As per the event description, there was a leak at the stopcock.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.In conclusion, based on the information available at this time it cannot be confirmed that the product failed to meet requirements.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.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer Contact: ronnie greco ; 4875 palm harbor blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 20886453
• Report Number: 1035166-2024-00143
• Device Sequence Number: 21001601
• 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): 01/09/2025

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: TG0654509
• Device Catalogue Number: TG0654509
• Device Lot Number: S9157083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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 Sex: Unknown