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

Model Number	98US006
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that during an implant procedure (patient involved), the physician used an mvsd 6 mm device, which should be compatible with the ods iii 6f delivery set.The device was inspected prior to use.However, upon reaching the curved part of the delivery set, the cable could not advance further.It lost pushability and was no longer responsive, preventing proper deployment.As a result, physician upsized to an ods iii 7f (98us007, lot; dp-21419), after which the device was successfully deployed.The patient recovered and event resolved.Additionally, a part of the loader came out of place while advancing the device, which resulted in blood spillage.The issue is related to the compatibility problem between the mvsd 6 mm and odsiii 6f.Clinically significant extended treatment or procedure time.The affected odsiii was discarded by the hospital.Please find the pictures attached as provided by customer.There was a delay, less than 30 minutes.No medical or surgical intervention was required.The procedure was completed successfully using the 7f delivery set.The patient's anatomy was normal, with no abnormalities or challenges noted during the procedure.
Additional Manufacturer Narrative
No product was provided for analysis as the device was discarded by the customer.Procedure completed successfully with different device.As per the event description, the issue is related to the compatibility problem between the mvsd 6 mm and odsiii 6f.A part of the loader came out of place while advancing the device, which resulted in blood spillage.The patient recovered and event resolved.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.Based on the investigation, a capa is not required.In addition, there was no new failure mode identified, and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.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.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, g3, g6, h2, h6 & h11.H2: additional information added.H6: corrected code from 1250 leaking to 1069 break.H11.Additional information provided by the customer.Photos of the defective device reviewed and therefore, updated the investigation summary to include the outcome and updated coding.No product was provided for analysis as the device was discarded by the customer.Procedure completed successfully with different device.As per the event description, the issue is related to the compatibility problem between the mvsd 6 mm and ods iii 6f.A part of the loader came out of place while advancing the device, which resulted in blood spillage.The patient recovered and event resolved.Based on the images provided by the customer it appears the loader mount hub came off.Since the product was discarded a device analysis cannot be completed.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.Based on the investigation, a capa is not required.In addition, there was no new failure mode identified, and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Integer will continue to monitor this event type and risk.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 have not 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: 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: ronnie greco ; 4875 palm harbor blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 22751071
• Report Number: 1035166-2025-00048
• Device Sequence Number: 18321856
• Product Code: DYB
• UDI-Device Identifier: 00885672010195
• UDI-Public: 00885672010195
• 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,Followup
• Report Date (Section B): 10/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 98US006
• Device Catalogue Number: 98US006
• Device Lot Number: DP-21553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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
• Patient Sex: Male