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

Model Number HLO54535

Device Problem Connection Problem (2900)

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

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 09/2022).

Event Description

It was reported that prior to a procedure, the sheath head could not be screwed properly.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: 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.During the evaluation the sheath luer hub was disconnected and reconnected to the hemostasis valve successfully.The connection was secure with no issue observed.No damage was observed on the hemostatis valve on the side tube or sheath luer hub.The result of the investigation is unconfirmed for the reported connection problem.The root cause for the reported connection problem 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.Precautions: 1.The halo one thin-walled guiding sheath shall only be used by trained physicians.Access procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment and / or ultrasound.7.Careful attention must be paid to the maintenance of tight valve connections for duration of procedure to avoid blood leakage or the introduction of air into the system.Take remedial action if any excessive blood leakage is observed.8.Insert dilator into the center of the sheath valve.Forced insertion of the dilator which misses the center of the valve may cause damage and result in blood leakage.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.11.Remove the dilator from the sheath slowly to avoid incomplete closing of the valve resulting in blood leakage.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 2.Prior to use, the air in the sheath and dilator should be removed.To facilitate purging, the device is packaged with the dilator inside the sheath in a reverse direction allowing both to be flushed simultaneously.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 stopcock on the side-port of the sheath and flush with the sterile heparinized saline solution (figure 4).Close the stopcock to maintain the air tightness following flushing.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 4.Insert the provided vessel dilator through the hemostatic valve and click the dilator hub into place in the valve housing h10: d4 (expiry date: 09/2022), g3, h6 (method) h11: h6 (result, conclusion) 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.H3 other text : see h10.

Event Description

It was reported that prior to a procedure, the sheath head could not be screwed properly.The procedure was completed using another device.There was no patient contact.

• Brand Name: HALO ONE THIN-WALLED GUIDING SHEATH
• Type of Device: 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: 13468538
• MDR Text Key: 285171151
• Report Number: 9616666-2022-00007
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741161926
• UDI-Public: (01)00801741161926
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLO54535
• Device Catalogue Number: HLO54535
• Device Lot Number: CMEX0375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• 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