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

Catalog Number	HLO61035F
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that during an angioplasty procedure, the dilator was allegedly ruptured.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2026), g3.H11: d4, h6 (method).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 an angioplasty procedure, the dilator was allegedly ruptured.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the dilator was allegedly ruptured.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
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 this event.Investigation summary: the sample was returned for evaluation.Two dilators were returned.One dilator was the original bd dilator returned separate to the sheath.A 4mm split was confirmed on the dilator tip.A second 20cm 5fr dilator of unknown origin was returned inserted within the halo sheath.One image was also provided for review.The tip of a dilator was shown placed over the reverse side of a halo packaging label.The dilator tip was split, the split length could not be determined.The result of the investigation is confirmed reported dilator split damage issue.The root cause for the reported dilator split damage issue could not be determined based upon the available information received from the field communications, device evaluation and image review.Labeling review: the instruction for use for this halo one device 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.Contraindications: there are no known contraindications for the halo one¿ thin-walled guiding sheath.Warnings: 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.2.Do not resterilize.After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications.Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.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.7.Do not use a power injector through the sideport or the three-way stopcock.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.11.Failure to deactivate the procedural device prior to removal through the sheath may cause damage to the sheath and may result in patient injury.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.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.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.14.Ensure to deactivate the procedural device prior to removal through the sheath.15.Take care when back loading the tip of the dilator over the guidewire to avoid damage to the dilator.16.Ensure the dilator is securely connected with the sheath prior to advancing otherwise only the sheath may advance into the vessel and the sheath tip may cause damage to the vessel.17.Ensure the dilator is in place within the sheath before advancing the sheath as otherwise damage may be caused to the vessel.18.Do not place sutures on the sheath tubing since this may restrict access/flow through the sheath.When puncturing, suturing or incising near the sheath be careful not to damage the sheath.Proper functioning of the sheath depends on its integrity.Care should be used when handling the sheath.19.If using fluid injection through the 3 way stopcock, ensure the dilator or procedural device is not in place at the same time.20.If resistance is felt during post-procedure withdrawal of the procedural device, it is recommended to remove the procedural device, guidewire, and sheath as a single unit.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.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.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 flush with the sterile heparinized saline solution.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.Use of the halo one¿ thin-walled guiding sheath: 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.Remove the dilator slowly while holding the sheath in place and ensuring the guidewire remains in place 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 while maintaining the sheath position.14.Position the procedural device relative to the lesion to be treated.Ensuring the active mechanism portion of the procedural device is not within the sheath.15.Following use ensure the procedural device is fully deactivated before carefully withdrawing the procedural device through the sheath while maintaining the sheath position.16.After the procedure is completed insert the dilator over the wire into the sheath.17.Slowly withdraw the sheath and dilator as a unit and then remove the guide wire.D4 (expiry date: 03/2026).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.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18026642
• Report Number: 9616666-2023-00200
• Device Sequence Number: 7664992
• Product Code: DYB
• UDI-Device Identifier: 00801741161964
• UDI-Public: (01)00801741161964
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup
• Report Date (Section B): 12/05/2023

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 Catalogue Number: HLO61035F
• Device Lot Number: CMHR0082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 12/05/2023
• Initial Report FDA Received Date: 10/28/2023
• Supplement Report FDA Received Date: 11/24/2023; 12/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• 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