MAUDE Adverse Event Report: OSCOR INC. 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	03/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After management review for peeling issue capa was initiated to further investigate this issue.No product was returned to oscor inc.For evaluation; however, a complaint notification was provided.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Based on the information provided by the supporting documentation, 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.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.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
An 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.The procedure was completed, and the patient did not experience any adverse effects, harm, or require medical intervention because of this incident.These complaints are from the same customer as (b)(6) but no samples or photos were provided.Product disposed.Additional complaints associated with comp (b)(4) are as follows: (b)(4).

• Brand Name: SAFESHEATH® ULTRA LITE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer (Section G): OSCOR INC.; 4875 palm harbor blvd.; palm harbor 34683
• Manufacturer Contact: daniel naut ; 4875 palm harbor blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 19166718
• Report Number: 1035166-2024-00036
• Device Sequence Number: 7855632
• 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): 04/23/2024

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
• Device Lot Number: DP-18918
• 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: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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 Sex: Unknown