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

Model Number	HLO41035F
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
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: 03/2022).
Event or Problem Description
It was reported that during the removal procedure through femoral region, the tip of the catheter was allegedly broken and separated from the opaque mark.There was no reported patient injury.
Event or Problem Description
It was reported that during a process in the right femoral region and upon removal, the tip of the catheter was allegedly found to have broken off and separated.The device was snared out of the body.There was no reported patient injury.
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 returned for evaluation.The result of the investigation confirmed that the distal tip and marker band were torn off from the sheath.The distal tip and marker band were severely deformed.The extensive damage to the sheaths distal area, indicates that excessive force by the user had been applied during its use.In conclusion, the investigation confirms the material split, cut or torn and unconfirmed for material separation and break.The root cause for the reported material separation and break 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: warnings: 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: 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.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.14.Ensure to deactivate the procedural device prior to removal through the sheath.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.H10: b5, d4 (expiry date: 03/2022), g3.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.

• 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
• MDR Report Key: 11460120
• Report Number: 9616666-2021-00025
• Device Sequence Number: 19700776
• Product Code: DYB
• UDI-Device Identifier: 10801741161824
• UDI-Public: (01)10801741161824
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K192313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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: HLO41035F
• Device Catalogue Number: HLO41035F
• Device Lot Number: CMER0250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other