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 Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 04/2022).
Event or Problem Description
It was reported that during preparation, the connection between luerlock and sheath are allegedly loosen.The procedure was completed by using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4(expiry date: 04/2022),g3 h11: b5,h1,h6(patient) 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a procedure, the luer lock cannot be properly connected.It was reported that the sheath was opened by its own and the patient experienced significant blood loss.The procedure was completed using another device.The patient status is unknown.
Event or Problem Description
It was reported that during a procedure, the luer lock cannot be properly connected.It was reported that the sheath was opened by its own and the patient experienced significant blood loss.The procedure was completed using another device.The patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was discarded at the facility and not returned for evaluation.The result of the investigation is inconclusive for the reported connection problem issue.The definitive root cause for the reported connection problem issue could not be determined based upon the available information received from the field communications.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 h10: d4 (expiry date: 04/2022), g3 h11: h6 (method) 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.H3 other text : device not returned.

• 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
• MDR Report Key: 11504513
• Report Number: 9616666-2021-00030
• Device Sequence Number: 11477171
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HLO61035F
• Device Catalogue Number: HLO61035F
• Device Lot Number: CMES0080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 04/26/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/15/2021; 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other