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

Model Number	D141101
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Difficult to Remove (1528); Difficult to Advance (2920); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when inserting the heliostar into the sheath and then slowly aspirating, a lot of bubbles were visible coming out of the guidestar sheath tubing.The physician used a large syringe and straightened the heliostar shaft in order to minimize any air coming in through the valve but air bubbles were still seen.He then pushed the heliostar catheter a bit further into the sheath (2-3cm) and no more bubbles were seen and we were able to proceed with the procedure.After ablating the rspv and when trying to canulate the ripv, the physician pulled back the heliostar balloon into the sheath but wasn't able to do so.He tried to use a bit more force it but without success.There was no deflection on the sheath or the heliostar catheter.He then pushed the heliostar out of the sheath, inflated and performed ablation on the ripv but when he tried again to pull it back, the catheter was still getting stuck at the distal end of the sheath.The physician then decided to pull the entire system out due to the risk of perforation if he continued to try to force the heliostar back.With the sheath and the heliostar out of the patient, we then tried to do the same maneuvers repeatedly but couldn't pull the heliostar back past the distal portion of the sheath.We could clearly see now that the distal tip of the sheath would bend with the force being applied when pulling the heliostar.After several attempts and without flow on the sheath and heliostar, after pushing the heliostar forward, deflecting and re-deflecting the curve, we were able to remove the heliostar from the sheath.When we removed the heliostar, we noticed that there was leaking from the side of the valve of the sheath (the portion that connects to the handle.There was no patient complication reported.There was 30 min delay reported and procedure completed successfully.
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Additional Manufacturer Narrative
Our investigation is still in progress, follow up report will be submitted if we find any further additional information.
Event or Problem Description
It was reported that when inserting the heliostar into the sheath and then slowly aspirating, a lot of bubbles were visible coming out of the guidestar sheath tubing.The physician used a large syringe and straightened the heliostar shaft in order to minimize any air coming in through the valve but air bubbles were still seen.He then pushed the heliostar catheter a bit further into the sheath (2-3cm) and no more bubbles were seen and we were able to proceed with the procedure.After ablating the rspv and when trying to canulate the ripv, the physician pulled back the heliostar balloon into the sheath but wasn't able to do so.He tried to use a bit more force it but without success.There was no deflection on the sheath or the heliostar catheter.He then pushed the heliostar out of the sheath, inflated and performed ablation on the ripv but when he tried again to pull it back, the catheter was still getting stuck at the distal end of the sheath.The physician then decided to pull the entire system out due to the risk of perforation if he continued to try to force the heliostar back.With the sheath and the heliostar out of the patient, we then tried to do the same maneuvers repeatedly but couldn't pull the heliostar back past the distal portion of the sheath.We could clearly see now that the distal tip of the sheath would bend with the force being applied when pulling the heliostar.After several attempts and without flow on the sheath and heliostar, after pushing the heliostar forward, deflecting and re-deflecting the curve, we were able to remove the heliostar from the sheath.When we removed the heliostar, we noticed that there was leaking from the side of the valve of the sheath (the portion that connects to the handle.There was no patient complication reported.There was 30 min delay reported and procedure completed successfully.
Additional Manufacturer Narrative
The following sections were updated in follow-up: b4, d9, g3, g6, h2, h3, h6, and h10: device was used in treatment.One 13.5f guidestar steerable guiding sheath was received without the dilator.There were no other accessories.Traces of blood were found on and inside the sheath.According to the event description summary, bubbles were visible coming out of the guidestar sheath tubing and there was leaking from the side of the valve of the sheath after the heliostar balloon catheter was removed.Also, the physician was having difficulty removing the balloon catheter from the sheath, but eventually was able to do so.The valve was viewed under a 10x microscope and looked normal with no anomalies.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.A fit check was performed with a sample 13.5f dilator.The sample dilator passed fully and smoothly all the way through the sheath.There is also a kink in the sheath shaft approximately 9cm from the distal tip that most likely occurred while trying to remove the balloon catheter.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.The probable cause of leakage during use could have been the handling of ancillary device(s) in conjunction with the sheath.A fit check using a sample 13.5f dilator confirmed that the inner diameter of the sheath was within spec.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 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 at aql level ansi z 1.4, gen level i, normal, aql 1.5 normal.All of the following procedures are performed 100%: tipping inspection: using 10x microscope, visually inspect the surface of the distal tip both inside and the outside.Using a laser microscope, verify the o.D.(outer diameter) of the sheath in three different spots (distal section, mid-section and proximal section) of the body in dim "a", to confirm that the unit meets the requirements according to the drawing.Using the appropriate pin gauge, measure id of shaft according to drawing.The pin gauge should be inserted at distal tip of shaft.Dilator insertion: the tooling dilator is inserted into the proximal end of the shaft to assure inner lumen is free of obstructions.The dilator should pass smoothly without resistance thru the proximal end of the shaft all the way thru until it is protruding at distal tip.There should be minimal gap between shaft and dilator at distal end.Inspection for obstruction: a sample tipped dilator of appropriate size is inserted into the proximal hubbed end of the shaft to assure the inner lumen is free of obstructions.The dilator should pass smoothly without resistance thru the proximal end of the shaft all the way thru until it is protruding at distal tip.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.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
• 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
• Manufacturer Contact: doug myers ; 3816 desoto blvd; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 13440278
• Report Number: 1035166-2022-00021
• Device Sequence Number: 11290319
• 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): 07/01/2022

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: 04/01/2023
• Device Model Number: D141101
• Device Catalogue Number: D141101
• Device Lot Number: C8-19565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown