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

Model Number HLO52535H

Device Problems Unraveled Material (1664); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/15/2021

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 return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 03/2023.

Event Description

It was reported that during an angioplasty procedure, a gel like substance was allegedly identified at the tip of the device upon insertion after being wetted with saline.The substance was reported to seem like a lump of the peeled coating from the device.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, a gel like substance was allegedly identified at the tip of the device upon insertion after being wetted with saline.The substance was reported to seem like a lump of the peeled coating from the device.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.However, device history record review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned to the manufacturer for evaluation.However, two images were provided.Review of these images point to the substance been bodily/blood residue, however due to images quality the substance cannot be confirmed.No images of the device were provided.The root cause for the reported device contamination issue could not be determined based upon the available information received from the field communications and images review.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: 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.Precautions: 1.Contents supplied sterile using ethylene oxide (eto).Non-pyrogenic.Do not re-use, reprocess or re-sterilize.This device is intended for single use only.Contamination which may lead to infectious complications.Cleaning, reprocessing 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.6.Carefully inspect the sheath prior to use to verify that the sheath has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.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.21.In order to activate the hydrophilic coating, it is recommended to wet the halo one thin-walled guiding sheath with heparinized saline solution immediately prior to its insertion in the body.Failure to activate the coating may lead to sub-optimal trackability of the sheath.To maintain lubricity this surface must be kept completely wet.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.Storage: store in a cool, dry, dark place.Rotate inventory so that the catheter and other dated products are used prior to the ¿use by¿ date.Do not use if packaging is damaged or opened.Directions for use: halo one thin-walled guiding sheath preparation: 1.Verify the french size is suitable for the procedure and can accommodate the required procedural devices as labeled (figure 3).Remove sheath and dilator from package.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 flushed with the sterile heparinized saline solution.Close the stopcock to maintain the air tightness following flushing.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).5.In order to activate the hydrophilic coating, where labeled, it is recommended to wet the halo one thin-walled guiding sheath with sterile saline solution immediately prior to its insertion in the body.H10: d4 (expiry date: 03/2023).H11: section a through f ¿ the information provide by bd represents all 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 : device not returned.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13219308
• MDR Text Key: 284642670
• Report Number: 9616666-2021-00253
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741184857
• UDI-Public: (01)00801741184857
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLO52535H
• Device Catalogue Number: HLO52535H
• Device Lot Number: CMFR0175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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