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

Model Number	D141101
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.
Event or Problem Description
After heliostar catheter insertion, the physician slowly aspirated the sheath with a small syringe, when no more bubbles were visible he flushed it a bit, without applying much pressure.When doing this, there was sprinkling from the side of the valve of the sheath handle.The physician also reported that this has been a common occurrence lately.No patient harm reported.
Additional Manufacturer Narrative
B5: on (b)(6) 2022 the customer stated that the product was used for an afib - paroxysmal procedure.There was no delay in the procedure; however, the patient outcome is unknown.It is unknown what could have caused the sheath - air leak.One 13.5f guidestar steerable guiding sheath was received with the dilator.There were no other accessories.Blood was found on and inside the sheath and dilator.According to the event description summary, there was sprinkling from the side of the valve of the sheath handle.The valve was viewed under magnification and looked normal with no anomalies.The sides of the hub and cap were also viewed under magnification and there were no cracks or any other anomalies found.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 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, sideport 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 did not leak when tested manually.The sheath also met the iso leakage test method requirement and did not leak through the hemostatic valve, hub or handle as shown in the customer's video.The handle, hub and hub caps looked normal and intact when viewed under magnification.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 (b)(4).Per qa procedure (b)(4).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.
Event or Problem Description
On (b)(6) 2022 the customer stated that the product was used for an afib - paroxysmal procedure.There was no delay in the procedure; however, the patient outcome is unknown.It is unknown what could have caused the sheath - air leak.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING SHEATH
• Common Device Name: 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: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13498118
• Report Number: 1035166-2022-00026
• Device Sequence Number: 11790544
• Product Code: DYB
• UDI-Device Identifier: 00885672009496
• UDI-Public: 00885672009496
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140406
• 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): 06/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-19826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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