MAUDE Adverse Event Report: OSCOR INC. OCCLUTECH DELIVERY SET III; INTRODUCER, CATHETER

Model Number	98DL010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; however, a complaint notification was provided.There was no device performance issue reported, so no investigation is required.The customer reported percutaneous removal (means removal of kidney stones).The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.The complaint is non-verifiable as the product was not returned for evaluation.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
Summary: device dislocation / embolization.The event occurred during patient contact.Consequences of event: percutaneous removal (means removal of kidney stones).Event notified to authority.[description / sequence of events]: perivalvular regurgitation closure procedures were undertaken.A pld was implanted via the tf approach and an odsiii was inserted to implant a second pld when the initially implanted pld became dislodged.The pld was located in the left atrium and retrieved with a snare catheter.An attempt was made to resume the pld implantation procedure, but the patient's blood pressure dropped, and the procedure was abandoned and terminated.Patient condition resolved.The device was discarded by the hospital.(b)(6) 2024: tf is transfemoral (tf) and pld is our occlutech paravalvular leak device.Again, may i please clarify the reported 98dl010; lot: dp-21333 is not a complaint and has not been given any complaint number from us as well.(b)(4) is assigned to the occlutech paravalvular leak device only.Please provide us only the batch record review for the mentioned ods iii only since the customer claimed for one.[note]: all medical records, including cts, are not available.[reportability in japan]: this event is reportable to pmda.Jll# (b)(4).

• Brand Name: OCCLUTECH DELIVERY SET III
• 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: 20745489
• Report Number: 1035166-2024-00131
• Device Sequence Number: 15525693
• Product Code: DYB
• UDI-Device Identifier: 00885672010324
• UDI-Public: 00885672010324
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K210627
• 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): 11/21/2024

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: 98DL010
• Device Catalogue Number: 98DL010
• Device Lot Number: DP-21333
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 85 YR
• Patient Sex: Male