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

Model Number	LSMU1350616
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device is expected to be returned.The investigation is on-going.
Event or Problem Description
It was reported that the device became stuck in a 6fr cook ansel sheath during advancement into the lesion.The doctor prepped the device.There were no anomalies noted during the prep of the device.There was no damage noted to the box, tray or stent cover and no difficulty removing the stent cover.The patient was being treated for sma stenosis mesenteric ischemia.A 6f, 45 cm ansel 2 introducer sheath and a 0.035, 260 cm rosen guidewire were used.The device was attempted to be inserted through the 6f sheath however resistance was felt just past the valve of the sheath.An attempt was made to retract the device from the sheath however this was unsuccessful as the stent was stuck.The stent remained stuck in the introducer sheath.Air evacuation was not performed prior to inserting the device.Multiple attempts to insert the device were not made.There was no reported patient injury.However, the access site was lost.

• Brand Name: LIFESTREAM
• Common Device Name: BALLOON EPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 6797689
• Report Number: 9616666-2017-00062
• Device Sequence Number: 132023
• Product Code: PRL
• UDI-Device Identifier: 05391522081468
• UDI-Public: (01)05391522081468
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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 Expiration Date: 01/31/2020
• Device Model Number: LSMU1350616
• Device Catalogue Number: LSMU1350616
• Device Lot Number: CMBP0065
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR