MAUDE Adverse Event Report: OSCOR INC. ANGIODYNAMICS SAFESHEATH® ULTRA LITE; INTRODUCER, CATHETER

Model Number	VI85
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the peel away mechanism did not work well, and the physician had to rely on using a hemostat to tear away the sheath from the catheter.The procedure was successfully completed, and the patient did not experience any adverse effects, harm, or require medical intervention.The devices will not be returned for evaluation, as they were disposed of.There are two different sheaths packaged into this one upn kit, it contains two different lot numbers (dp-18917 or dp-18918).It was reported that neither lot number could be confirmed as to which lot number was involved in this incident.The device history records were reviewed for both lot numbers, and confirmed the devices passed all applicable in-process and final inspections.No products were returned to oscor inc.For evaluation as they were disposed of; however, a complaint notification was provided.Without the return of the actual devices in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.At this time, it is not possible to assign a definitive root cause for the event as reported.After management review for peeling issues, a capa was initiated to further investigate into this issue.The complaint is non-verifiable as the product was not returned for evaluation.The event will be re-evaluated should 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.
Event or Problem Description
Event date and procedure dates are both (b)(6) 2024; event occurred in the usa and no patient information was provided.The device was used for treatment; problem was noticed during a port placement procedure.End user reported an issue with the sheath in a ct w/8fr detached poly cath w/vi smartport kit.It was reported that the peel away mechanism did not work well, and the physician had to rely on using a hemostat to tear away the sheath, from the catheter.Procedure was completed successfully with this device, and the patient did not experience any adverse effects, harm, or require medical intervention.Device will not be returned for evaluation, as it was disposed of.There are two lot numbers that went into the one upn kit; it was reported that neither lot number could be confirmed as to which lot number was involved in this incident (dp-18917 or dp-18918).

• Brand Name: ANGIODYNAMICS SAFESHEATH® ULTRA LITE
• 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 ; 7279372511
• MDR Report Key: 19204702
• Report Number: 1035166-2024-00040
• Device Sequence Number: 8034215
• Product Code: DYB
• UDI-Device Identifier: 25051684026281
• UDI-Public: 25051684026281
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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 Model Number: VI85
• Device Catalogue Number: VI85
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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