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

Model Number HLO54535

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/06/2021

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: 01/2023).Device pending return.

Event Description

It was reported that during an angioplasty procedure, the coated part of the sheath was allegedly rough and foreign substance like chocolate adhered to the device.There was no patient contact.

Event Description

It was reported that during an angioplasty procedure, the coated part of the sheath was allegedly rough and foreign substance like chocolate adhered to the device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.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.Opaque fibers were noted on a section of the sheath measuring 13mm in length commencing 28mm from the sheath tip.The majority of the distal end of the sheath was dull indicating, absence of hydrophilic coating.There was no evidence of the reported chocolate like substance on the sheath.It is unlikely the opaque fibres and absence of hydrophilic coating were manufacturing related.A 100% visual inspection for device defects is performed during sheath production.The result of the investigation is confirmed for the reported sheath contamination issue.The root cause for the reported sheath contamination issue could not be determined based upon the available information.Labeling review: instructions for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: warnings: 3.This device has been designed for single use only.Reusing this medical device bears the risk of cross-patient contamination as medical devices ¿ particularly those with long and small lumina, joints, and/or crevices between components ¿ are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time.The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.4.Visually inspect the packaging to verify that the sterile barrier is intact.Do not use if the sterile barrier is opened or damaged.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.21.In order to activate the hydrophilic coating, it is recommended to wet the halo one¿ thin-walled guiding sheath with heparinized saline solution immediately prior to its insertion in the body.Failure to activate the coating may lead to sub-optimal trackability of the sheath.To maintain lubricity this surface must be kept completely wet.18.Do not place sutures on the sheath tubing since this may restrict access/flow through the sheath.When puncturing, suturing or incising near the sheath be careful not to damage the sheath.Proper functioning of the sheath depends on its integrity.Care should be used when handling the sheath.H10: d4 (expiry date: 01/2023), g3 h11: h6 (method, result, 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.

• 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: 12411935
• MDR Text Key: 269541467
• Report Number: 9616666-2021-00138
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741161926
• UDI-Public: (01)00801741161926
• 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: 09/27/2021

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: HLO54535
• Device Catalogue Number: HLO54535
• Device Lot Number: CMFP0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1