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

Model Number	98DS008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up will be submitted as soon as the investigation is complete.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
The customer reported the sheath had kinked.This occlutech delivery set iii (odsiii) 8f model 98ds008, lot number dp-19033 was used in a ventricular septal defect (vsd) closure procedure.The vsd closure could not be finished, and the patient my need surgery.No surgical intervention yet.The procedure delay was no more than 30 minutes.A second odsiii was used in this procedure.Dp-19004 is processed under (b)(4).
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, d9, g1, g3, g6, h2, h3, h6 & h11.One 8f occlutech delivery set was returned under rga# rg24103/ca without the dilator or loader.There were no other accessories.Blood was found on and inside the sheath.According to the event description summary, the end user thinks the malfunction (kinked sheath) occurred when going through the patient's anatomy.Upon evaluation of the returned product, it was found that there was a kink in the sheath shaft approximately 4cm from the distal tip.Per manufacturing procedure (breezeway ii shaft assembly).100% in-process inspection.· using a microscope (10x), inspect the sheath for exposed braid, proper braid termination, proper marker band placement, and shaft assembly damages (kinks and skive tool marks).Per qa procedure (breezeway ii guiding sheath shaft assembly).Shaft assembly/reflow in-process inspection.Sample size: ansi / asq z1.4 general level i, aql 0.25, normal.· inspect reflowed shaft for dents, scratches, bumps, cracks, wrinkles, kinks, exposed braid or marker band or delamination.Final assembly: sample size: inspect per ansi z 1.4, gen level 1, normal, and aql 0.40.· check that the sheath body is free from kinks or dents.Check for fm.The instructions for use (ifu) informs the user: never advance, torque, or withdraw sheath when resistance is met.Determine cause by fluoroscopy and then take remedial action.Returned device analysis revealed the sheath was within manufacturing specifications.The sheath shaft was kinked approximately 4cm from the distal tip.It was stated in the event description that the end user thought the malfunction (kinked sheath) occurred when going through the patient's anatomy.Potential causes of the kink could have been due to an unsupported sheath, excess torque during use or resistance once inserted into the patient's body due to tortuous anatomy.According to the device history records (dhr), the sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.No manufacturing defects were found.In conclusion, based on the information available at this time it cannot be confirmed that the product failed to meet requirements.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: OCCLUTECH DELIVERY SET III
• 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: ronnie greco ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 19176428
• Report Number: 1035166-2024-00034
• Device Sequence Number: 3770596
• Product Code: DYB
• UDI-Device Identifier: 00885672010249
• UDI-Public: 00885672010249
• 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): 07/26/2024

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 Expiration Date: 05/01/2026
• Device Model Number: 98DS008
• Device Catalogue Number: 98DS008
• Device Lot Number: DP-19033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG