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

Model Number	HLO61035F
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional 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: 06/2022).
Event or Problem Description
It was reported that prior to the procedure, the luer lock connection allegedly came loose and the sheath opens by itself.The procedure was completed by using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to the procedure, the luer lock connection allegedly came loose and the sheath opens by itself.The procedure was completed by using another device.There was no patient contact.
Additional Manufacturer Narrative
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 sample was returned for evaluation.The result of the investigation is unconfirmed for the reported connection problem.During the evaluation the sheath luer hub was reconnected to the hemostasis valve successfully.The connection was secure with no issue observed.No damage was observed on the hemostatis valve on the side tube or sheath luer hub.The root cause for the reported connection problem could not be determined based upon the available information.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: precautions: 7.Careful attention must be paid to the maintenance of tight valve connections for duration of procedure to avoid blood leakage or the introduction of air into the system.Take remedial action if any excessive blood leakage is observed.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.11.Remove the dilator from the sheath slowly to avoid incomplete closing of the valve resulting in blood leakage.Potential adverse effects: hemorrhage, including bleeding at the puncture site.D4 (expiry date: 06/2022).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.
Event or Problem Description
It was reported that prior to the procedure, the luer lock connection allegedly came loose and the sheath opens by itself.The procedure was completed by using another device.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number.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.During the evaluation the sheath luer hub was reconnected to the hemostasis valve successfully.The connection was secure with no issue observed.No damage was observed on the hemostatis valve on the side tube or sheath luer hub.Therefore, the investigation is unconfirmed for the reported connection problem.The root cause for the reported connection problem could not be determined based upon the available information received from the field communications and sample evaluation.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: precautions: 7.Careful attention must be paid to the maintenance of tight valve connections for duration of procedure to avoid blood leakage or the introduction of air into the system.Take remedial action if any excessive blood leakage is observed.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.11.Remove the dilator from the sheath slowly to avoid incomplete closing of the valve resulting in blood leakage.Potential adverse effects: hemorrhage, including bleeding at the puncture site.D4 (expiry date: 06/2022).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
• Common Device Name: 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: 12352853
• Report Number: 9616666-2021-00129
• Device Sequence Number: 4333047
• Product Code: DYB
• UDI-Device Identifier: 10801741161961
• UDI-Public: (01)10801741161961
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: HLO61035F
• Device Catalogue Number: HLO61035F
• Device Lot Number: CMEU0493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 03/01/2022
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/17/2021; 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown