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

Model Number	98DS009
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Arrhythmia (1721); Tachycardia (2095)
Type of Reportable Event	Serious Injury
Event or Problem Description
Reason: air embolus in delivery system noticed during implantation of pfo (occlutech implant) using ods iii.Possible incidence of ventricular arrhythmias noted.Please be informed of the new odsiii complaint.Customer complaint will follow soon.I will be glad to forward your additional questions to the customer.Notification to occlutech: 2nd april, location: (b)(6), date: to be investigated, products: ods iii and pfo (product codes and serial numbers being investigated), devices: pfo implanted as planned, no further complications.Ods iii not retrieved."[?]" patient: no complications reported, action: local agent will obtain more clinical information.
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.Integer 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 integer 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, integer, or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, integer, or its employees, that the report constitutes an admission that the device, integer, or its employees caused or contributed to the event described in this report.

• Brand Name: OCCLUTECH DELIVERY SET III
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: mohit malkani ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 24931600
• Report Number: 1035166-2026-00023
• Device Sequence Number: 10727345
• Product Code: DYB
• UDI-Device Identifier: 00885672010270
• UDI-Public: 00885672010270
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2026

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: 98DS009
• Device Catalogue Number: 98DS009
• Device Lot Number: S10185525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 06/17/2026; 08/10/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/17/2026; 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 149 LB