MAUDE Adverse Event Report: OSCOR INC. GUIDESTAR¿ STEERABLE GUIDING SHEATH; INTRODUCER, CATHETER

Model Number D141103

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported the guidestar sheath was leaking and valve seemed to not work right.Unfortunately the guidestar was thrown away.Procedure was successful by changing out catheter.No patient consequences.No additional information available.

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up 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.

Manufacturer Narrative

The following sections were updated in follow-up 1: b4, g3, g6, h2, h6, and h10 the device was used in the treatment.The device was discarded and not returned for analysis; therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.The following controls are in place to mitigate the reported product issue.Per manufacturing procedure adelante magnum and destino magnum sheath assembly: sample size 100%: the valves are visually inspected before final assembly.Leak test cured sheath assemblies per procedure.Per qa procedure destino steerable guiding sheath in-process and final inspection: sample size: ansi z 1.4, gen level i, normal, aql 1.5 normal perform leak test according to procedure based on available leak tester.The leak test is performed by manufacturing personnel at 100% and is observed by quality assurance personnel the instructions for use (ifu) informs the user: the steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Aspiration and flushing of the sheath should be performed frequently to help minimize the potential for air embolism.For injecting or aspirating through the sheath, use the sideport only with stopcock.Prior to infusion, remove all air using the sideport.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.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: GUIDESTAR¿ STEERABLE GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• 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
• MDR Report Key: 15685407
• MDR Text Key: 303184172
• Report Number: 1035166-2022-00114
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672010911
• UDI-Public: 00885672010911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D141103
• Device Catalogue Number: D141103
• Device Lot Number: DP-16237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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