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

Model Number D141101

Device Problem Air/Gas in Device (4062)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

It was reported that small air bubbles in irrigation tubing from sheath was visible.Aspiration was needed.No patient harm reported.

Manufacturer Narrative

Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.

Manufacturer Narrative

The following sections were updated in follow-up 1.One 13.5f guide star steerable guiding sheath was received without the dilator.There were no other accessories.Blood was found on and inside the sheath.According to the event description summary, small air bubbles were seen in the side port tubing.The hemostatic valve was viewed under magnification and looked normal with no anomalies.The sheath was aspirated with the tip submerged into water and a syringe connected to the stopcock.When the plunger of the syringe was pulled back, water was drawn into the sheath fully and smoothly.No bubbles were seen inside the side port tubing.The sheath was manually leak tested with the syringe connected to the stopcock and the tip occluded.The sheath did not exhibit leakage when tested using this method.The sheath was then leak tested using the iso 11070 for liquid leakage test method.The device was occluded at the distal tip and pressurized to 38kpa and held at this pressure for 30 seconds and no leakage was observed from the hemostatic valve.The sheath was further pressurized beyond 300kpa and no leakage was observed from the stopcock, side port tubing or through the handle.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Returned device analysis revealed the sheath was within manufacturing specifications.The sheath aspirated fully and smoothly and no bubbles were observed inside the side port tubing.The sheath did not leak when tested manually and also met the iso leakage test method requirement.According to the dhr, the sheath passed all in-process and final inspection steps including visual, mechanical, dimensional and leak testing.No manufacturing defects were found.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 procedures based on available leak tester.The leak test is performed by manufacturing personnel at 100% and is observed by quality assurance personnel at aql level ansi z 1.4, gen level i, normal, aql 1.5 normal.Per ifu 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.No further follow-up is required.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 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13666158
• MDR Text Key: 290051779
• Report Number: 1035166-2022-00034
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00885672009496
• UDI-Public: 00885672009496
• 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: 08/08/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-19802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1