MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH

Model Number	HLO57035
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a recanalization procedure of the common femoral artery to access the splenic artery aneurysm, resistance was allegedly felt when advancing the device.The device was removed off the patient and upon examination, the dilator tip of the device was allegedly noted to be damaged.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 09/2025).Device pending return.
Additional Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was returned for evaluation.A guidewire was not returned.The patency of the returned sheath and dilator was performed using an inhouse 0.035¿ guidewire without any issue.Five splits were confirmed on the dilator tip ranging in length from 0.5mm - 3.5mm.The result of the investigation inconclusive for the failure to advance issue.The result of the investigation is confirmed for the reported dilator tip damage issue.The root cause for the reported failure to advance and dilator tip damage issues could not be determined based upon the available information.Labeling review: instructions for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: indication for use the halo one thin-walled guiding sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices.The halo one thin-walled guiding sheath is not indicated for use in the neurovasculature or the coronary vasculature.Warnings: 6.Do not advance the guidewire, sheath/dilator, procedural device, or any component if resistance is met, without first determining the cause and taking remedial action.10.Only advance or retract the sheath with the dilator inserted and only advance or retract the sheath and dilator while placed over a properly sized guidewire.Precautions: 4.The minimum acceptable sheath french size is printed on the package label.Do not attempt to pass devices through a smaller size sheath introducer than indicated on the device label.5.The pouch should be inspected prior to opening to ensure the sterile barrier is not compromised.The device should be carefully removed and placed in the sterile field.The entire procedure from skin puncture or incision to sheath withdrawal must be carried out aseptically.9.Advance or withdraw the sheath slowly.If resistance is met do not advance or withdraw until the cause of resistance is determined.10.When inserting, manipulating or withdrawing a device through the introducer always maintain the introducer position.12.When using procedural devices close to the tip of the sheath care must be taken to ensure the active mechanism portion of the procedural device (e.G., balloon, stent zone, material removal section of atherectomy device) is not within the tip of the sheath.The radiopaque marker is located within 5 mm of the end of the tip but does not mark the true distal tip of the sheath.13.Before removing or inserting the interventional/diagnostic device through the sheath, aspirate blood from the 3-way stopcock to remove any fibrin deposition which may have accumulated in or on the tip of the sheath.22.Proper functioning of the halo one thin-walled sheath depends on its integrity.Care should be used when handling the sheath.Damage may result from kinking, stretching, or forceful wiping of the halo one thin-walled guiding sheath.Do not continue to use the sheath if the shaft has been bent or kinked.Directions for use: 3.Prior to use the reverse loaded dilator must be removed from the distal end of the sheath.If not already completed at step 2, the air in the dilator lumen should be removed.To facilitate purging, select a syringe or inflation device with a 10 ml or larger capacity and fill approximately half of it with sterile saline solution.Prepare the lumen by connecting the syringe or inflation device containing the solution into the luer connector of the dilator hub and flushing with the sterile heparinized saline solution (figure 7).4.Insert the provided vessel dilator through the hemostatic valve and click the dilator hub into place in the valve housing (figures 5 and 6).7.At the operator¿s discretion, make a small skin incision at the puncture site with a surgical scalpel.Recommended for scar tissue at the access site.8.Backload the distal tip of the halo one thin-walled guiding sheath dilator over the prepositioned guidewire and advance the tip to the introduction site.9.Advance the dilator and the sheath through the skin and into the vessel.Grasp the sheath and dilator assembly close to the skin while advancing to avoid buckling, employ a rotating motion while advancing as required.(note: if using a hydrophilic guidewire, ensure that it is kept hydrated with sterile heparinized saline, at all times.) 10.Carefully advance the dilator and the sheath over the wire to the site required within vessel.The radiopaque marker identifies the sheath tip location under fluoroscopy 11.Disconnect the dilator hub from the valve by bending to the side to unsnap from the valve cap (figure 8).Remove the dilator slowly while holding the sheath in place and ensuring the guidewire remains in place (figure 9) as required.12.Load the procedural device over the pre-positioned guidewire.13.Advance the procedural device carefully into the centre of the valve diaphragm and through the sheath to the treatment site (figure 10) while maintaining the sheath position.H10: d4 (expiry date: 09/2025).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during a recanalization procedure of the common femoral artery to access the splenic artery aneurysm, resistance was allegedly felt when advancing the device.The device was removed off the patient and upon examination, the dilator tip of the device was allegedly noted to be damaged.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: HALO ONE THIN-WALLED GUIDING SHEATH
• Common Device Name: GUIDING SHEATH
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13665342
• Report Number: 9616666-2022-00036
• Device Sequence Number: 20022648
• Product Code: DYB
• UDI-Device Identifier: 00801741161933
• UDI-Public: (01)00801741161933
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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 Model Number: HLO57035
• Device Catalogue Number: HLO57035
• Device Lot Number: CMEX0360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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