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

Model Number	LSMU1350858
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the stent was deployed from the balloon.The patient status is unknown.
Additional 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 or Problem Description
It was reported that the stent was deployed from the balloon.The patient status is unknown.

• Brand Name: LIFESTREAM
• Common Device Name: 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
• Report Number: 9616666-2020-00039
• Device Sequence Number: 3468284
• Product Code: PRL
• UDI-Device Identifier: 05391522081239
• UDI-Public: (01)05391522081239
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: LSMU1350858
• Device Catalogue Number: LSMU1350858
• Device Lot Number: CMDY0309
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60