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

Model Number HLO59035

Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/19/2021

Event Type  malfunction  

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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2022).

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery, resistance was allegedly felt during advancing over the guidewire.It was further reported that a viscous substance was found adhered to the physician's glove and a large amount of the same gel substance was identified at the insertion site as well.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure in the superficial femoral artery, resistance was allegedly felt during advancing over the guidewire.It was further reported that a viscous substance was found adhered to the physician's glove and a large amount of the same gel substance was identified at the insertion site as well.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 returned for evaluation.The result of the investigation is confirmed for the reported contamination issue.A gel substance was observed and removed from the hub of the halo dilator.A blood like substance was also removed from within the dilator.The result of the investigation is inconclusive for the reported difficulty to advance issue.A 0.035" guidewire was successfully passed through the dilator device and gel substance during the evaluation.The definitive root cause for the reported contamination and difficulty to advance issues could not be determined based upon the available information received from the field communications, device evaluation and images provided.Labeling review: instructions for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: warnings: 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.Precautions: 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.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.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 (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.H10: d4 (expiry date: 07/2022).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.

• 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: 11452404
• MDR Text Key: 238857400
• Report Number: 9616666-2021-00024
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741161940
• UDI-Public: (01)00801741161940
• 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: 04/06/2021

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
• Device Operator: Health Professional
• Device Model Number: HLO59035
• Device Catalogue Number: HLO59035
• Device Lot Number: CMEV0266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other