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

Model Number	TG0709009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Vascular Dissection (3160)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an endurant iis stent graft system was implanted in the patient for the endovascular treatment of a 71 mm abdominal aortic aneurysm on (b)(6) 2018.Ct was performed on (b)(6) 2021, due to abdominal pain, where an endoleak type 1a was observed.In addition, dissection was observed by ivus as well as angiography, extending from the left subclavian to the level of the celiac.The physician believed that the dissection was probably caused by the sheaths used in the snorkels in concert with the patient's possible connective tissue disorder.As per the physician, cause of the endoleak event was that the patient may have a degenerative disease due to the fact that every place where the stent graft touched aortic wall, we have had degeneration and growth over the last 3 years.The patient is not an open surgical candidate, or she would receive an open repair.The dissection was not observed until the end of the intervention.Cause of the dissection is unknown.The user didn't report device performance issue.No further treatment is planned at this time.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned, it was discarded.There was no product performance issue reported.No further treatment is planned at this time, patient is scheduled for close surveillance.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Based on the investigation, a capa is not required.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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12423290
• Report Number: 1035166-2021-00101
• Device Sequence Number: 4377908
• Product Code: DYB
• UDI-Device Identifier: 00643169936249
• UDI-Public: 00643169936249
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: TG0709009
• Device Catalogue Number: TG0709009
• Device Lot Number: C8-21936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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: Female