MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX; PTA BALLOON DILATATION CATHETER

Catalog Number 425-2004X

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 12/12/2017

Event Type  malfunction  

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.Receipt of device is not expected.The investigation is currently in progress.

Event Description

It was reported that the device failed to cross the lesion and kinked.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The complaint device and another device were inserted into the patient however the devices failed to cross the lesion and kinked.It was unknown how the procedure completed.The procedure completed successfully.There was no reported patient injury.

Manufacturer Narrative

It was reported that the device failed to cross the lesion and kinked.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The complaint device and another device were inserted into the patient however the devices failed to cross the lesion and kinked.It was unknown how the procedure completed.The procedure completed successfully.There was no reported patient injury.

• Brand Name: SLEEK RX
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: fiona nimhullain ; 539237111
• MDR Report Key: 7133086
• MDR Text Key: 96052104
• Report Number: 9616666-2017-00153
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K072947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 425-2004X
• Device Lot Number: 50136776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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