Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH Back to Search Results
Model Number HLO54535
Device Problems Difficult to Insert (1316); Material Separation (1562); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
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: 05/2022).
 
Event Description
It was reported that prior to a procedure, the device allegedly separated while insertion.The procedure was completed using another device.There was no patient contact.
 
Event Description
It was reported that prior to a procedure, the device allegedly separated while insertion.It was further reported that the device allegedly difficult to advance.The procedure was completed using another device.There was no patient contact.
 
Manufacturer Narrative
H10: manufacturing review: 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 result of the investigation is confirmed for the reported material split issue.Two longitudinal splits on opposite planes of the dilator tip were observed on the returned device.One measured 2mm in length and other 3.5mm in length.The end of the tip was also deformed.It is unlikely that the dilator tip damage is manufacturing related, as a 100% visual inspection for device defects is performed during manufacture.The results of the investigation is inconclusive for the reported advancement issue.The definitive root cause for the reported material split and advancement issues could not be determined based upon the available information received from the field communications, device evaluation and image provided.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: 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.15.Take care when back loading the tip of the dilator over the guidewire to avoid damage to the dilator.H10: b5, d4 (expiry date: 05/2022).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.
 
Event Description
It was reported that prior to a procedure, the device allegedly separated while insertion.It was further reported that the device allegedly difficult to advance.The procedure was completed using another device.There was no patient contact.
 
Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.However, a device history record review was performed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was returned for evaluation.Two longitudinal splits on opposite planes of the dilator tip were observed on the returned device.One measured 2mm in length and other 3.5mm in length.The end of the tip was also deformed.Therefore, the result of the investigation is confirmed for the reported material split issue.However, the results of the investigation is inconclusive for the reported advancement issue.The definitive root cause for the reported material split and advancement issues could not be determined based upon the available information received from the field communications, device evaluation and image provided.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: 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.15.Take care when back loading the tip of the dilator over the guidewire to avoid damage to the dilator.H10: d4 (expiry date: 05/2022), g3.H11: g1, h6 (result).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11722660
MDR Text Key247210550
Report Number9616666-2021-00052
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00801741161926
UDI-Public(01)00801741161926
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K192313
Number of Events Reported1
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,Followup
Report Date 11/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHLO54535
Device Catalogue NumberHLO54535
Device Lot NumberCMET0574
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-