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

Model Number HLO62535H

Device Problems Difficult to Insert (1316); Unraveled Material (1664); Failure to Advance (2524)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2023).

Event Description

It was reported that during an angioplasty procedure, the sheath was allegedly unable to insert and sheath tip peel off.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the sheath was allegedly difficult to insert and sheath tip peel off.It was further reported that another device was used to complete the procedure.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, 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.The result of the investigation is inconclusive for the reported difficult to insert and unraveled material issues.The root cause for the reported difficult to insert and unraveled material issues could not be determined based upon the available information received from the field communications.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.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.) h10: d4 (expiry date: 01/2023), g3, 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.

• 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
• MDR Report Key: 12208497
• MDR Text Key: 262876205
• Report Number: 9616666-2021-00117
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741184871
• UDI-Public: (01)00801741184871
• Combination Product (y/n): N
• PMA/PMN Number: K192313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLO62535H
• Device Catalogue Number: HLO62535H
• Device Lot Number: CMFP0140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other