MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT

Model Number LSMU1350938

Device Problem Packaging Problem (3007)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

It was reported that prior to a stent graft placement procedure, the product box was allegedly damaged and found wet upon opening.There was no patient contact.

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review 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.Expiration date: 04/2025.Device not returned.

Event Description

It was reported that prior to a stent graft placement procedure, the product box was allegedly damaged and found wet upon opening.The procedure was completed using another 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 lot number and the lot met all release criteria.A device history record review is not required.Investigation summary: the sample was not returned for evaluation.The result of the investigation is inconclusive for the reported packaging damage issue.The root cause for the reported packaging damage issue could not be determined based upon the available information.Labeling review: the instructions for use for the lifestream product was reviewed and contains the following information relevant to the reported event: warnings; ¿ do not use if packaging/pouch is damaged.Storage; store in a cool, dry place.Keep away from sunlight.Use the device prior to the use by date specified on the package.Directions for use; 4.Carefully remove the selected device from the package.5.Inspect the covered stent for adherence to the balloon and centered placement in relation to the balloon marker bands.If the covered stent is not centered and/or does not firmly adhere to the balloon, do not use.H10: b5, d4 (expiry date: 04/2025), g3, 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.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15137431
• MDR Text Key: 297910499
• Report Number: 9616666-2022-00169
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081260
• UDI-Public: (01)05391522081260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU1350938
• Device Catalogue Number: LSMU1350938
• Device Lot Number: CMGS0036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1