MAUDE Adverse Event Report: INTEGER HOLDINGS CORPORATION OCCLUTECH DELIVERY SET III; INTRODUCER, CATHETER

Model Number	98US011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; there was no device performance issue reported, so no investigation is required.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.Per the instructions for use (ifu), air embolism is listed as a potential adverse effect associated with use of the device.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.
Event or Problem Description
Please be informed of the new odsiii complaints, details below.Event description: transient st elevation with bradycardia consistent with air embolism complained product: 98ds011; dp-18374 (no device return).Please note that there was no direct complaint related to the odsiii product; however, due to the occurrence of air embolism, the event's relationship to the product/procedure was assessed as possible.There was a causal relationship for this event (st elevation during the procedure).Additional medication / treatment given because of the occurrence of this adverse event.Procedural time was 171 min.Two attempts were performed for deploying of medical accessory.There were no signs of thrombosis.Country of event - germany, patient status / outcome - resolved (might need an update) & procedure being performed at the time the issue was identified as an atrial septal defect (asd) closure.

• Brand Name: OCCLUTECH DELIVERY SET III
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): INTEGER HOLDINGS CORPORATION; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer (Section G): INTEGER HOLDINGS CORPORTATION; 4875 palm harbor blvd.; palm harbor FL 34683
• Manufacturer Contact: ronnie greco ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 24314832
• Report Number: 1035166-2026-00008
• Device Sequence Number: 12181701
• Product Code: DYB
• UDI-Device Identifier: 00885672010348
• UDI-Public: 00885672010348
• 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): 02/11/2026

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 Expiration Date: 03/01/2026
• Device Model Number: 98US011
• Device Catalogue Number: 98US011
• Device Lot Number: DP-18374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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: Unknown