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

Model Number	LSMU0800726
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/08/2020
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 (09/2020).
Event or Problem Description
It was reported that during balloon expandable stent deployment procedure, the device allegedly failed to insert device through the introducer sheath.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this was the first complaint reported for this lot number.Based on the severity and lot quantity the number of events is below the acceptable quality level.Investigation summary: the device was returned to the manufacturer for evaluation.The device was successfully advanced through a 6fr 10cm terumo sheath during evaluation despite resistance being met.The stent sleeve was not returned.The investigation is unconfirmed for the reported device incompatibility issue.The definitive root cause for the reported device incompatibility issue could not be determined based upon information labeling review: the instructions for use (ifu) 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: this supplemental mdr is being submitted to report that initial emdr was inadvertently submitted with g4 mdr date of awareness as 09-jun-2020.The correct g4 date is 08-jun-2020.H10: d4 (expiry date: 09/2020), g4.H11: d2(type of device).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 during balloon expandable stent deployment procedure, the device allegedly failed to insert device through the introducer sheath.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this was the first complaint reported for this lot number.Based on the severity and lot quantity the number of events is below the acceptable quality level.Investigation summary: the device was returned to the manufacturer for evaluation.The device was successfully advanced through a 6fr 10cm terumo sheath during evaluation despite resistance being met.The stent sleeve was not returned.The investigation is unconfirmed for the reported device incompatibility issue.The definitive root cause for the reported device incompatibility issue could not be determined based upon information labeling review: the instructions for use (ifu) 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 (expiry date: 09/2020), g4.H11: d3,h6 (method, result and conclusion).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 during balloon expandable stent deployment procedure, the device allegedly failed to insert device through the introducer sheath.The procedure was completed using another device.There was no patient contact.

• Brand Name: LIFESTREAM
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford AZ N A ; EI N A
• MDR Report Key: 10211190
• Report Number: 9616666-2020-00046
• Device Sequence Number: 2613687
• Product Code: PRL
• UDI-Device Identifier: 05391522081093
• UDI-Public: (01)05391522081093
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/11/2020

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: LSMU0800726
• Device Catalogue Number: LSMU0800726
• Device Lot Number: CMBX0412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 09/08/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 09/03/2020; 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 75