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

Catalog Number LSM1350637

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

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 device was returned for evaluation.The image is that of the life stream device returned.It shows the distal section of the device where the stent is present on the balloon and the shaft section connected to the balloon.In the background a coiled section of the shaft is visible.A pinch (highlighted as a red outline in the image) is noted on the shaft close to the proximal bond.The pinch damage matches that of the returned device.The investigation is confirmed for the reported material deformation issue.There were two pinches noted on the outer, one at the exit of the strain relief and the other at the proximal bond.It is likely that handling or user related issues during the removal of the sleeve during device preparation contributed to the event.The investigation was unconfirmed for the reported device incompatibility issue.Although slight resistance was felt when passing through the pinch in the proximal area, a 0.035" guidewire was successfully passed through the device during the evaluation.The definitive root cause for the reported issues could not be determined based upon information received from the field communications, image review and device evaluation.Labeling review: the instructions for use for the life stream product was reviewed and contains the following information relevant to the reported event: potential adverse events ¿ covered stent deformation / kink / fracture directions for use site access and preparation 1.Using standard techniques access the artery and place an introducer sheath or guiding catheter of appropriate inner diameter and a 0.035" (0.89 mm) guidewire across the target lesion.The catalog number identified in section d4 has not been cleared in the us but is similar to the life stream that are cleared in the us.The pro code and 510k number for the life stream is identified in d2 and g5.(expiry date: 11/2021),h6(method: 3331) 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 Description

It was reported that during preparation for a stent placement procedure, the guidewire failed to pass and the shaft was allegedly bent.There was no patient contact.

• Brand Name: LIFESTREAM
• Type of Device: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10748233
• MDR Text Key: 213471017
• Report Number: 9616666-2020-00101
• Device Sequence Number: 1
• Product Code: PRL
• UDI-Device Identifier: 05391522081482
• UDI-Public: (01)05391522081482
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P160024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: LSM1350637
• Device Lot Number: CMCZ0224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1