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

Model Number HLO52535H

Device Problems Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Pain (1994)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that during an angioplasty procedure, the sheath was allegedly unable to be inserted.It was further reported that the patient allegedly experienced pain.The patient current status was unknown.

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: 10/2022).

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is sixth complaint reported for this product / lot number combination.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 to the manufacturer for evaluation.The evaluation of the retuned device exhibited minor deformation on the sheath tip.Three splits on the dilator tip of the following lengths: 11mm, 5m & 1 mm were also observed.Therefore, the investigation is confirmed for the reported insertion failure issue.The root cause for the reported insertion failure issue could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: 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.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.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.15.Take care when back loading the tip of the dilator over the guidewire to avoid damage to the dilator.Directions for use: 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 (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.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.12.Load the procedural device over the pre-positioned guidewire.H10: d4 (expiry date: 10/2022), g3, h6 (device).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 : see h10.

Event Description

It was reported that during an angioplasty procedure, the sheath was allegedly unable to be inserted.It was further reported that the patient allegedly experienced pain.The patient current status was unknown.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12906272
• MDR Text Key: 281508957
• Report Number: 9616666-2021-00212
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLO52535H
• Device Catalogue Number: HLO52535H
• Device Lot Number: CMEY0155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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
• Patient Outcome(s): Other