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

Model Number	LSMU1350858
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2020
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.Expiry date (12/2020).
Event or Problem Description
It was reported that prior to a procedure, the size and the lot number of the device was not found to be the same as mentioned on the package.There was no patient contact.
Event or Problem Description
It was reported that prior to a procedure, the size and the lot number of the device was not found to be the same as mentioned on the package.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Investigation summary: the sample was returned to the manufacturer for evaluation.The device returned matched with the inner packaging received (lot # cmcn0323).The device carton received (lot # cmcv0514) did not match with the inner packaging.It is unlikely that the mislabelled product issue is manufacturing related as there were 8 months between the manufactured of both lots numbers i.E.Lot # cmcn0323 was manufactured on the 18th of january 18 and lot # cmcv0514 was manufactured on the 29th of august 18.Both product lots were also verified using the bvs packing application system during manufacturing.It is likely that the mislabelled product issue occurred at the user facility site.The result of the investigation is confirmed for the reported mislabelled product issue.The root cause for the reported distorted issue could not be determined based upon the available information received from the field communications, device evaluation and images of the packaging provided.Labeling review: endovascular system refer to the product labels for the balloon compliance chart and for the covered stent dimensions (post nominal pressure and post rated burst pressure inflation).D.Warnings: do not use if packaging/pouch is damaged.H11: section a through f ¿ 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
• 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: 10687133
• Report Number: 9616666-2020-20004
• Device Sequence Number: 2836448
• 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): 12/03/2020

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: CMCN0323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 01/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other