MAUDE Adverse Event Report: OSCOR INC ADELANTE MAGNUM; INTRODUCER, CATHETER

Model Number	ASM018030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that there was blood loss through the thermostatic valve.Procedure completed successfully.No patient consequences reported.No additional information is available.
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.The exact cause of the product issue cannot be determined.The investigation was focused on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.However, the following controls are in place to mitigate the reported product issue.Per adelante magnum introducer sheath in-process and final inspections / adelante® magnum.Perform pressure and vacuum leak test per procedure 4 latest revision.Sampling plan ansi z 1.4, gen level i, normal, aql 0.15.Per ifu: remove the dilator, catheter, or other device slowly from the sheath.Rapid removal may damage the valve resulting in blood flow through the valve.Insert the dilator through the center of the sheath hemostatic valve to prevent tearing of the seal and leakage.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 MAGNUM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 13440634
• Report Number: 1035166-2022-00024
• Device Sequence Number: 2046170
• Product Code: DYB
• UDI-Device Identifier: 00885672004743
• UDI-Public: 00885672004743
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140917
• 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): 07/15/2022

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: 09/01/2024
• Device Model Number: ASM018030
• Device Catalogue Number: ASM018030
• Device Lot Number: DP-14088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown