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

Model Number 426-2015X

Device Problems Material Rupture (1546); Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One device was returned for evaluation.The lot history review was performed.The investigation confirmed for material rupture, material deformation, and stretched.A root cause has not been determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.The information reviewed indicated that model 426-2015x pta balloon dilatation catheter allegedly experienced rupture, stretched material, and material deformation.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.

• 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
• 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: 9183012
• MDR Text Key: 194473671
• Report Number: 9616666-2019-00121
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741133619
• UDI-Public: (01)00801741133619
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 426-2015X
• Device Catalogue Number: 426-2015X
• Device Lot Number: 50139792
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1