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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH
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CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH Back to Search Results
Model Number HLO51035F
Device Problems Device Damaged Prior to Use (2284); Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2022).
 
Event Description
It was reported that during the procedure through common femoral antegrade, the sheath allegedly had a longitudinal split at the distal portion.It was further reported that the device allegedly failed to advance.The procedure was completed using another device.There was no reported patient injury.
 
Event Description
It was reported that during the procedure through common femoral antegrade, the sheath allegedly had a longitudinal split at the distal portion it was further reported that the device allegedly failed to advance.The procedure was completed using another device.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 device was not returned for evaluation.Review of an image supplied observed a split at the dilator distal tip.The result of the investigation is confirmed for the material deformation and failure to advance issues.The definitive root cause for the reported device damaged prior to use, material deformation and failure to advance issues could not be determined based upon the available information received from the field communications 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: ¿ visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.¿ 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.¿ 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: ¿ the pouch should be inspected prior to opening to ensure the sterile barrier is not compromised.The device should be carefully removed and placed in the sterile field.The entire procedure from skin puncture or incision to sheath withdrawal must be carried out aseptically.¿ 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.H10: d4 (expiry date: 04/2022),.
 
Event Description
It was reported that during the procedure through common femoral antegrade, the sheath allegedly had a longitudinal split at the distal portion it was further reported that the device allegedly failed to advance.The procedure was completed using another device.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 device was not returned for evaluation.Review of an image supplied observed a split at the dilator distal tip.The result of the investigation is confirmed for the material deformation and failure to advance issues.The result of the investigation is inconclusive for the reported device damaged prior to use issue.The definitive root cause for the reported device damaged prior to use, material deformation and failure to advance issues could not be determined based upon the available information received from the field communications 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: ¿ visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.¿ 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.¿ 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: ¿ the pouch should be inspected prior to opening to ensure the sterile barrier is not compromised.The device should be carefully removed and placed in the sterile field.The entire procedure from skin puncture or incision to sheath withdrawal must be carried out aseptically.¿ 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.H10: d4 (expiry date: 04/2022), the device was not returned.
 
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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 Key12121346
MDR Text Key260676573
Report Number9616666-2021-00099
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10801741161909
UDI-Public(01)10801741161909
Combination Product (y/n)N
PMA/PMN Number
K192313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHLO51035F
Device Catalogue NumberHLO51035F
Device Lot NumberCMES0325
Was Device Available for Evaluation? No
Date Manufacturer Received09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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