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

Model Number HLO61035F

Device Problem Connection Problem (2900)

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

Event Date 07/14/2021

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.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2022).Device pending return.

Event Description

It was reported that prior to a procedure, the luer-lock connector was allegedly loosened and the entire hemostatic valve disconnected when the physician pulled out the shaft from the stent.The procedure was completed by using another device.There was no patient contact.

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 this event.Investigation summary: the physical sample was returned for evaluation and photo was provided for review.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 hemostatic valve on the side tube or sheath luer hub.The result of 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, sample evaluation and image review.Labeling review: instructions 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: 04/2022).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 Description

It was reported that prior to a procedure, the luer-lock connector was allegedly loosened and the entire hemostatic valve disconnected when the physician pulled out the shaft from the stent.The procedure was completed by using another device.There was no patient contact.

• 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: 12307119
• MDR Text Key: 266004861
• Report Number: 9616666-2021-00125
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801741161961
• UDI-Public: (01)10801741161961
• 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: 09/06/2021

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: HLO61035F
• Device Catalogue Number: HLO61035F
• Device Lot Number: CMES0062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1