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

Model Number D141101

Device Problems Fluid/Blood Leak (1250); Device Damaged by Another Device (2915)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

During an afib - paroxysma procedure, when retracting the heliostar balloon into the guidestar sheath, the physician experienced a lot of resistance and couldn't get the heliostar balloon back without applying a lot of force.The physician re-inflated and then deflated the balloon (for 30 seconds) and attempted to pull the balloon back into the sheath.The physician noticed that when pulling the balloon back, the sheath would deflect with the force applied until it finally released and the tip of the sheath would spring.This occurred only on the right pulmonary veins.At the end of the procedure, when pulling the catheter out the physician noticed a lot of leaking from the valve (hub).There was no delay in procedure and it was successfully completed.No patient harm was reported.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The device was used in treatment.One 13.5f guidestar steerable guiding sheath was received back from the customer with the dilator.There were no other accessories.Traces of blood were found on and inside the sheath and dilator.According to the event description summary, the balloon catheter could not be withdrawn from the sheath without applying a lot of force.It was also stated that the sheath leaked and the sheath did not deflect.Since the balloon catheter was not returned, a fit check was performed using the dilator.The dilator passed fully and smoothly all the way through the sheath and was easily withdrawn from the sheath with no issues.The hemostatic valve looked normal with no anomalies.The sheath was manually leak tested with the syringe connected to the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 (b)(4) 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 or through the handle.The sheath would also no longer deflect.X-rays revealed that the anchor ring and pullwire remained in its original intended position.The hypotubes were intact.The sheath would no longer deflect due to the broken pullwire which was located approximately 5cm from the distal tip.According to the device history records (dhr), the introducer sheath passed all in-process and qa final inspection steps before shipping to the customer including visual, dimensional, mechanical and leak testing.Returned device analysis revealed the sheath is within manufacturing specifications.According to the event description summary, the balloon catheter could not be withdrawn from the sheath without applying a lot of force.It was also stated that the sheath leaked and the sheath did not deflect.The dilator passed fully and smoothly all the way through the sheath.The sheath did not leak when tested manually and also met the iso leakage test requirement.The sheath would also no longer deflect.It is likely that the force it took to push and pull the balloon in and out of the sheath contributed to the breakage of the pullwire causing the sheath to no longer deflect.No manufacturing defects were found.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 at aql level ansi z 1.4, gen level i, normal, aql 1.5 normal.The deflection test is performed 100% by manufacturing personnel as per procedure and inspected by quality personnel at an aql level (sample size: ansi z 1.4, gen level i, normal, aql 1.5).A deflection inspection fixture is used to verify the centerline of the sheath to meet the applicable deflection criteria.Before the sheath is deflected, the unit is ensured that the distal tip of the sheath is aligned with the distal engraved line of the template.For unidirectional models, verify the deflection knob is set to 0.Place the deflection section of the device on the applicable template as shown in figures below and deflect the device until the curve falls within the applicable deflection template.Verify the device can deflect to 170° (nominal 180° - 10°) on half the template.Dilator insertion: sample size 100%.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.The instructions for use (ifu) informs the user: preparing steerable sheath for insertion: verify deflecting and straightening of the distal section of the steerable sheath using the handle of the sheath.Refer to deflecting and straightening the steerable sheath" for instructions.General use of the steerable sheath: do not force the steerable sheath assembly if significant resistance is encountered during the insertion or passage.If resistance is encountered, determine the cause and correct before continuing the procedure.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 ; 7279372511
• MDR Report Key: 14115240
• MDR Text Key: 290052333
• Report Number: 1035166-2022-00052
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• 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: C8-19616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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