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

Model Number 425-3004X

Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation identified break, failure to advance, and material deformation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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

This report summarizes one malfunction.A review of the reported information indicated that model 425-3004x pta balloon dilatation catheter allegedly experienced failure to advance, material deformation, and break.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient¿s age, weight, and gender were not provided.

• Brand Name: SLEEK RX 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: 9182919
• MDR Text Key: 191036046
• Report Number: 9616666-2019-00113
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132414
• UDI-Public: (01)00801741132414
• 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: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 425-3004X
• Device Catalogue Number: 425-3004X
• Device Lot Number: CMBN0455
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1