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

Model Number	LSMU1350737
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2020
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.The investigation of the reported event is currently underway.(expiration date: 08/2021).
Event or Problem Description
It was reported that prior to a stent placement procedure, while flushing, they attempted to take the guard and the stent allegedly came off the balloon.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to a stent placement procedure, while flushing, they attempted to take the guard and the stent allegedly came off the balloon.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation.The investigation is inconclusive for the dislodgement and packaging issues reported.The definitive root cause for the reported dislodgement and packaging issues could not be determined based upon information received from the field communications.Labeling review: the instructions for use 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.H10: d4 (expiration date: 08/2021),g4.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
• 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: 10571911
• Report Number: 9616666-2020-00084
• Device Sequence Number: 3073782
• Product Code: PRL
• UDI-Device Identifier: 05391522081147
• UDI-Public: (01)05391522081147
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: LSMU1350737
• Device Catalogue Number: LSMU1350737
• Device Lot Number: CMCW0393
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1