MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH® II

Model Number SS6

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Event Description

When attempting to peel away the introducer it seemed more 'rigid' than normal.Had to use scissors to cut, it happened with two introducers from same box (model and lot number).The issue was resolved and completed successfully by using another accessory (introducer).No indication of product returning for evaluation.No adverse patient effects were reported.

Manufacturer Narrative

No product was provided for analysis.When attempting to peel away the introducer it seemed more 'rigid' than normal.Had to use scissors to cut, it happened with two introducers from same box (model and lot number).The issue was resolved and completed successfully by using another accessory (introducer).There was no adverse event with the patient.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.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.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.The instructions for use (ifu) adelante safesheath ii, 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 apart while withdrawing from the vessel.No further follow-up is required.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: SAFESHEATH® II
• Type of Device: SAFESHEATH® II
• 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: 18990209
• MDR Text Key: 338773731
• Report Number: 1035166-2024-00019
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 30891492002211
• UDI-Public: 30891492002211
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SS6
• Device Catalogue Number: SS6
• Device Lot Number: DP-19676
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1