MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. HALO ONE 70CM X 5F X 035; GUDING SHEATH

Model Number	HLO57035
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
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 sample is pending.The investigation of the reported event is currently underway.(expiry date: 03/2022).
Event or Problem Description
It was reported that prior to the procedure the guidewire was being loaded on to the guiding sheath, the guiding sheath was found allegedly contaminated with a milky substance.There was no reported patient contact.
Additional 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.Per the complaint history review, this is the first complaint reported for this product/lot number combination.Investigation summary: one sample was returned for evaluation and was confirmed as being a halo one device.The result of the investigation is confirmed for the reported contamination issue.There was evidence of white fibres on the distal side of the sheath.The source of the white fibres contamination was likely due from transfer by the hcp.It was reported that the hcp induced "more forceful rubbing, thread-like structures emerged on the sheath".There was no evidence of milky substance present on the sheath.Blood was observed on the dilator and the sheath.The sheath was undamaged.The root cause for the reported contamination issue could not be determined based upon the available information received from the field communications and device evaluation.Labeling review: instruction for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: precautions: 5.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.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.H10: d4 (expiry date: 03/2022).H11: h6 (method, results and conclusion) 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 guidewire was being loaded on to the guiding sheath, the guiding sheath was found allegedly contaminated with a milky substance.There was no patient contact.

• Brand Name: HALO ONE 70CM X 5F X 035
• Common Device Name: GUDING SHEATH
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 10653385
• Report Number: 9616666-2020-20001
• Device Sequence Number: 2743610
• Product Code: DYB
• UDI-Device Identifier: 00801741161933
• UDI-Public: (01)00801741161933
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 11/05/2020

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: HLO57035
• Device Catalogue Number: HLO57035
• Device Lot Number: CMER0172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 12/25/2020
• 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