MAUDE Adverse Event Report: OSCOR INC. ADELANTE SAFESHEATH LL 9F; INTRODUCER, CATHETER

Model Number	AS09013B5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, our investigation is still in progress.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
It was reported that we have had several situations where the oscor adelante safesheath ii has fractured in several pieces at the hub.It appears the hub assembly is not separating as it should.Additional information has been requested.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1: b4, g4, g7, h2, h6 and h10: device was used in treatment.The device was not returned for analysis, therefore, the clinical observation could not be confirmed.Several attempts were made to obtain additional patient and event information, also the location of the device but all attempts were unsuccessful.The investigation will focus on a review of product documentation.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.Per adelante-s introducer sheath in process and final inspection procedure: destructive testing, sampling plan ansi z 1.4, special, level 4, aql 0.40 reduced: 13.3.2, break and peel test: 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.Manually peel the sheath and verify the sheath peels easily along the sheath body and tip.The adelante safesheath ii instructions for use (ifu) informs the user: sharply snap the tabs of valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel sheath a part while withdrawing from the vessel.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.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 SAFESHEATH LL 9F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 9590612
• Report Number: 1035166-2020-00005
• Device Sequence Number: 19507199
• Product Code: DYB
• UDI-Device Identifier: 10885672002296
• UDI-Public: 10885672002296
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: AS09013B5
• Device Catalogue Number: AS09013B5
• Device Lot Number: DP10980
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1