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	04/01/2024
Type of Reportable Event	Malfunction
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 as a result of this incident.
Additional Manufacturer Narrative
One angiodynamics safesheath ultra lite introducer sheath was returned under rga# (b)(4) without the dilator.There were no other accessories.The sheath was already peeled apart.Blood was found on the sheath.According to the event description summary, 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.Upon receipt, the sheath was already peeled apart, but the valve did not break apart as intended.It was found that the valve was not sufficiently cut with the partial cut required to break the hemostatic valve in half.Since the valve wasn't sufficiently cut, it allowed the outer part of the valve to break and slip out from under the hub assembly when the sheath was peeled apart by the end user.Per manufacturing procedure (adelante-s sheath final assembly).· carefully inspect seals visually to ensure that the center star cut, and partial side cuts are present before assembly.Do not pull, bend or separate seals during inspection.If the seal is not properly cut, or tears/holes are present reject the seal and do not use for assembly.· 100 % inspection: perform a leak test on all adelante-s model sheath assemblies.Per manufacturing procedure (introducer set, silicone seal slitting) · once the cutting cycle is complete, the part will be placed on the machine tray.Remove the seal from the tray and perform a visual inspection using a 10x microscope.· finished center helix cut - verify the helix cut is complete and the seal was severed completely by checking for helix cut on the top and bottom of seal.Additional inspection for split seals · if the work order is for split seals prior to providing qa with the 5 samples, visually inspect and pull test the first 3 seals per section 7.4 seal pull test.If the pull tests are within specification, continue to run the first 5 samples for qa acceptance, visually inspect and submit to qa.Production may continue and seals may continue to be manufactured while pending the completion of the qa inspection.· partial cut - if the seal has a partial cut, ensure the cut did not cut through the full width of the seal (blade did not sever the membrane).Per qa procedure (adelante-s introducer sheath in process and final inspection) break and peel test: sampling plan: ansi z 1.4, special level 4, aql 0.40 reduced · using samples from fit check as described in 13.3.1, manually break the sheath and hub and verify that the seal splits easily without extreme elongation.Also verify that the split cap and seal remain secure and do not break free or loosen from the sheath hub.Leak test: sampling plan ansi z 1.4, gen level i, normal, aql 0.40 · the leak test is performed according to procedure.The leak test is performed by manufacturing personnel 100% and is observed by quality assurance personnel at an aql level.Per ifu: withdraw the sheath from the vessel.Then remove the sheath by sharply snapping the tabs of the valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel the sheath apart.Returned device analysis revealed hemostatic valve of the sheath did not break apart during use.The valve was not cut sufficiently enough to tear in half as intended.This occurred because valve was not sufficiently cut with the partial cut required to break the hemostatic valve in half.Since the valve wasn't sufficiently cut, it allowed the outer part of the valve to break and slip out from under the hub/hubcap assembly when the sheath was peeled apart by the end user.Manufacturing and qa personnel have been notified of this issue to raise awareness and were informed to pay close attention to this detail.Capa was opened to investigate the root cause and implement corrective action to prevent recurrence of this issue.According to the device history record, the introducer sheaths passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional and mechanical testing.In conclusion, based on the information available at this time it is 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: 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: 19163457
• Report Number: 1035166-2024-00035
• Device Sequence Number: 7948932
• Product Code: DYB
• UDI-Device Identifier: 25051684026281
• UDI-Public: 25051684026281
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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