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

Catalog Number LSMU0800637

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

H10: 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.H10: d4 (expiration date: 04/2026).H11: section a through f ¿ the information provided 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.H3 other text : device pending return.

Event Description

It was reported that prior to a stent placement procedure, the stent allegedly dislodged from the balloon upon removing the covered stent guard.It was further reported that the dislodged stent was put on the balloon and inserted into the patient.Reportedly, the balloon allegedly ruptured and the stent was failed to be placed.There was no reported patient injury.

Event Description

It was reported that prior to a stent placement procedure, the stent allegedly dislodged from the balloon upon removing the covered stent guard.It was further reported that the dislodged stent was put on the balloon and inserted into the patient.Reportedly, the balloon allegedly ruptured and the stent was failed to be placed.There was no reported patient injury.

Manufacturer Narrative

H10: this supplemental mdr is being submitted to report that mfr rpt# 9616666-2023-00186 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr rpt# 9616666-2023-00187.H10: d4 (expiration date: 04/2026).H11: section a through f ¿ the information provided 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.H3 other text : device pending return.

• 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: 17885195
• MDR Text Key: 325074882
• Report Number: 9616666-2023-00186
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081024
• UDI-Public: (01)05391522081024
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LSMU0800637
• Device Lot Number: CMHS0451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• 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