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

Model Number LSMU1350626

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of a procedure, the shaft was noted to be kinked upon removal from the packaging.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 second complaint reported for this product/lot number combination.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.The result of the investigation is unconfirmed for the reported shaft kink issue.There was no kinks or damage noted on the returned lifestream catheter shaft.The evaluation confirmed that the stent was dislocated by 4.5mm over the proximal marker bond.The patency of the lifestream was performed using an inhouse 0.035¿ guidewire but was unsuccessful.A blockage due to solidified blood present inside the inner.The root cause for the reported shaft kink issue could not be determined based upon the available information received from the field communications and sample evaluation.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.Should excessive resistance be felt at any time during the insertion process, do not force passage.Precautions: the device should only be used by physicians who are trained in endovascular procedures and are familiar with the complications, side effects and hazards of peripheral vascular interventions.Anatomical variances may complicate the procedure; use caution when advancing the endovascular system through tortuous or difficult anatomy.Directions for use: site access and preparation 1.Using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.2.Perform diagnostic angiography to confirm site of implantation and measure the reference vessel diameter and lesion length.Endovascular system preparation 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.6.Flush the delivery system guidewire lumen with sterile saline mixture until saline drops from the distal end of the endovascular system.(expiry date: 02/2023).The information provide by bd represents all 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: 14883397
• MDR Text Key: 295149392
• Report Number: 9616666-2022-00143
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081055
• UDI-Public: (01)05391522081055
• 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
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU1350626
• Device Catalogue Number: LSMU1350626
• Device Lot Number: CMEQ0234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2020
• 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