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

Catalog Number 426-2022X

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was performed.The sample was returned for evaluation.The investigation is confirmed for the detachment issue and material deformation.The root cause could not be determined at this time.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of reported information indicates that model 426-2022x, pta balloon dilatation catheter, allegedly experienced detachment and material deformation.This information was received from a single source.This malfunction did not involve a patient.

Manufacturer Narrative

H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation.The investiftion is confirmed for the detachment issue and material deformation.The root cause could not be determined at this time.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of reported information indicates that model 426-2022x, pta balloon dilatation catheter, allegedly experienced detachment and material deformation.This information was recieved from a single source.This malfunction did not involve a patient.

• Brand Name: SLEEK OTW PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9955500
• MDR Text Key: 195101801
• Report Number: 9616666-2020-00028
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 426-2022X
• Device Lot Number: CMDN0503
• Date Manufacturer Received: 04/21/2020
• Patient Sequence Number: 1