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

Model Number	D141103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported patient has bleeding groin.There is no reported performance issue associated with the guidestar.The patient is a 72-year-old male, that is part of a post-market clinical study named (b)(4) secure.During an atrial fibrillation procedure, the patient starting bleeding.It is unknown if any blood was lost, and when the bleeding occurred.The bleed was resolved with an intervention with compression bandage and steri-strips.The patient's outcome was reported as "recovered/resolved." there was no medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function.However, the patient was admitted to the hospital on (b)(6) 2023 and discharged on (b)(6) 2023.It was reported, in the opinion of the investigator in accordance with the list of expected events in the instructions for use, this adverse event was expected and, or anticipated.Customer made multiple attempts to obtain lot number and to get the device back, but attempts were not successful.The customer reported the root cause of reporting this event approximately 5 months after event, was due to human error by the team in charge of sending the notifications (events).
Additional Manufacturer Narrative
The device was not returned for analysis.There is no complaint against the guidestar.The device was used in a study (for treatment) and not returned for analysis.There was no device performance related failure reported by the user.This event is related to patient condition.No further investigation is required.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping to the customer.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: 17417438
• Report Number: 1035166-2023-00080
• Device Sequence Number: 12522127
• Product Code: DYB
• UDI-Device Identifier: 00885672010911
• UDI-Public: 00885672010911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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 Model Number: D141103
• Device Catalogue Number: D141103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male