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

Model Number	ASUP071318BNS
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The valve does not break when using the peel-off sleeve.We have to cut the valve manually.Two medical devices have been received.See images in attachment below.Clarification of events: (b)(4): the valve does not break when using the peel-away sheath.We have to manually cut the valve.Patient no affected.No consequences or impacts to patient.Incident date: on (b)(6) 2024 (b)(4): silicone valve on the peel away would not break and had to be cut with scissors or scalpel.Patient not affected.Incident date: on (b)(6) 2024.This complaint is associated w/(b)(4).
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report 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.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.B4, d9, g3, g6, h2, h3, h6 & h11.Two 7f adelante s lite introducer sheaths were returned under rma# 1202103991 without the dilators.The sheaths were already peeled apart upon receipt.Traces of blood were found on the product.According to the event description summary, the valve would not break apart and needed to be cut manually.Sheath 1 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.Sheath 2 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.The valve looks like it was cut 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, latest revision.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.Instructions for use: this product is shipped to the customer as bulk non-sterile, so the ifu is not provided at this at this time.Returned device analysis revealed hemostatic valve of both sheaths did not break apart properly during use.The valve was not cut sufficiently enough to tear in half as intended.Manufacturing and qa personnel have been notified of this issue to raise awareness and were informed to pay close attention to this detail.Capa 05374 was opened to investigate the root cause and implement corrective action to prevent recurrence of this issue.The corrective action (capa 05374) was deemed effective 08/23/2024.In conclusion, the review of the dhr did not identify any manufacturing anomalies of this type and passed all final testing prior to shipment, however, the stated failure of the returned product was confirmed by our investigation.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 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: ronnie greco ; 4875 palm harbor blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 20604520
• Report Number: 1035166-2024-00120
• Device Sequence Number: 12610827
• Product Code: DYB
• UDI-Device Identifier: 10885672104891
• UDI-Public: 10885672104891
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/09/2025

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: ASUP071318BNS
• Device Catalogue Number: ASUP071318BNS
• Device Lot Number: DP-18576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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