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

Model Number LSMU1350858

Device Problem Packaging Problem (3007)

Patient Problem Not Applicable (3189)

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, however photos have been provided.The investigation of the reported event is currently underway.(expiry date: 10/2022).

Event Description

It was reported that the stent was deployed from the balloon.The patient status is unknown.

Manufacturer Narrative

H10: this supplemental mdr is being submitted to report this file 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 mfg.Rpt.# 9616666-2020-00041.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 Description

It was reported that the stent was deployed from the balloon.The patient status is unknown.

• 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
• MDR Report Key: 10157213
• MDR Text Key: 195231024
• Report Number: 9616666-2020-00039
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081239
• UDI-Public: (01)05391522081239
• Combination Product (y/n): N
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSMU1350858
• Device Catalogue Number: LSMU1350858
• Device Lot Number: CMDY0309
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 60