MAUDE Adverse Event Report: OSCOR INC. ADELANTE® PEEL-AWAY INTRODUCER SET; INTRODUCER, CATHETER

Model Number	AP07016B5
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During implantation, before inserting the sheath, it is noticed that the tip of the introducer is frayed.No adverse patient effects were reported.Customer did not provide the event date, however, on (b)(6)2023, they submitted their event report form.Based upon this information, this is the date we are submitting as the event date.Should the actual event date be provided, we will update our report accordingly.
Additional Manufacturer Narrative
Customer did not provide the event date, however, on (b)(6) 2023, they submitted their event report form.Based upon this information, this is the date we are submitting as the event date.Should the actual event date be provided, we will update our report accordingly.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 event date is 05/jan/2023.Additionally, there was no procedure delay, no medical intervention or additional surgery required.The procedure was completed successfully using another product.No additional information available.
Additional Manufacturer Narrative
One 7f adelante introducer sheath was returned from the customer with the dilator, syringe and guidewire.There were no other accessories.No visible blood was found on or inside the sheath or dilator.According to the event description summary, during implantation, before inserting the sheath, it was noticed that the tip of the introducer is frayed.The material was not used, it was unpacked and prepared on the sterile table.After review of the returned product under a microscope, it was found that the tip of the sheath looked normal and round, but the tip of the dilator looked like it had sustained impact damage.Returned device analysis revealed the sheath and dilator were within manufacturing specifications.The tip of the sheath looked normal and the tip of the dilator looked like it had sustained impact damage.Potential contributing factors to the damage could have been if the device was dropped, bumped or mishandled.The dilator tips are inspected for damage by qa 100% during the packaging procedure, just prior to shipping to the customer.No manufacturing defects were found.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure (adelante introducer set in-process and final inspection): sampling plan ansi z 1.4, general level i, normal, aql 0.25 with the naked eye, verify the dilator/sheath are free of kinks, cracks, splits, sinks, excessive flash, loose/embedded fm, damaged tips or any other defects or damages on entire assembly.Per procedure (introducer kit packaging inspection): sample size 100% ensure dilator tip is perfectly round and well opened.The instructions for use (ifu) informs the user: do not advance the guidewire or introducer assembly under resistance.Determine the cause of resistance through fluoroscopic examination.Advance the sheath and dilator simultaneously to prevent damage to the sheath tip.No further follow-up is required.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.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.

• Brand Name: ADELANTE® PEEL-AWAY INTRODUCER SET
• 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279352511
• MDR Report Key: 16248954
• Report Number: 1035166-2023-00011
• Device Sequence Number: 6453327
• Product Code: DYB
• UDI-Device Identifier: 10885672100022
• UDI-Public: 10885672100022
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073100
• 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): 11/01/2023

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: 08/01/2026
• Device Model Number: AP07016B5
• Device Catalogue Number: AP07016B5
• Device Lot Number: DP-16383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2022
• 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: Unknown