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

Model Number	HLO64535
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Additional 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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 12/2023).As the lot number for the device was provided, a review of the device history records is currently being performed.The device (has or has not) been returned to the manufacturer for evaluation.However, photos/images/videos were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a procedure via renal intervention of a calcific lesion in the right sfa through a contralateral left approach, resistance was allegedly met and the device failed to advance.It was further reported that upon removal, the introducer was noted to be damaged.An access was gained from the opposite side and the device was recovered off the patient.The patient was reported to be in a stable condition.
Additional 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 not returned for evaluation, however an image was provided for review.The image provided was of poor resolution.It showed the distal section of what appears to be a halo dilator placed on blue / white material.The image confirmed the distal tip been badly damaged with at least 3 splits present.The split sections were spread apart.An image of the sheath was not provided.The result of the investigation is inconclusive for the reported sheath failure to advance and sheath material deformation issues.The root cause for the reported failure to advance and material deformation 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: 4.Visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.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.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.15.Take care when loading the tip of the dilator over the guidewire to avoid damage to the dilator.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.Directions for use: use of the halo one thin-walled guiding sheath 6.Identify the insertion site, including but not limited to radial, femoral, popliteal, tibial, or pedal access sites and prepare the site using proper aseptic technique and local anesthesia as required.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.14.Position the procedural device relative to the lesion to be treated (figure 11) ensuring the active mechanism portion of the procedural device is not within the sheath.H10: d4 (expiry date: 12/2023), g3, h6 (device, 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 a procedure via renal intervention of a calcific lesion in the right sfa through a contralateral left approach, resistance was allegedly met and the device failed to advance.It was further reported that upon removal, the introducer was noted to be damaged.An access was gained from the opposite side and the device was recovered off the patient.The patient was reported to be in a stable condition.
Event or Problem Description
It was reported that during a procedure via renal intervention of a calcific lesion in the right sfa through a contralateral left approach, resistance was allegedly met and the device failed to advance.It was further reported that upon removal, the introducer was noted to be damaged.An access was gained from the opposite side and the device was recovered off the patient.The patient was reported to be in a stable condition.
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 not returned for evaluation, however an image was provided for review.The image provided was of poor resolution.It showed the distal section of what appears to be a halo dilator placed on blue / white material.The image confirmed the distal tip been badly damaged with at least 3 splits present.The split sections were spread apart.An image of the sheath was not provided.The result of the investigation is confirmed for the reported sheath failure to advance and sheath material deformation issues.The root cause for the reported failure to advance and material deformation issues could not be determined based upon the available information received from the field communications and image review.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: 4.Visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.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.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.15.Take care when loading the tip of the dilator over the guidewire to avoid damage to the dilator.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.Directions for use: use of the halo one thin-walled guiding sheath: 6.Identify the insertion site, including but not limited to radial, femoral, popliteal, tibial, or pedal access sites and prepare the site using proper aseptic technique and local anesthesia as required.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.14.Position the procedural device relative to the lesion to be treated (figure 11) ensuring the active mechanism portion of the procedural device is not within the sheath.D4 (expiry date: 12/2023).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
• Common Device Name: THIN-WALLED 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: 13868758
• Report Number: 9616666-2022-00055
• Device Sequence Number: 4692011
• Product Code: DYB
• UDI-Device Identifier: 00801741223877
• UDI-Public: (01)00801741223877
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HLO64535
• Device Catalogue Number: HLO64535
• Device Lot Number: CMGN0243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 11/04/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/21/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White