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

Catalog Number UNKNOWN LITEPAC

Device Problems Crack (1135); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

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 investigation confirmed the reported crack and material deformation. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.

Event Description

This report summarizes one malfunction. A review of the reported information indicates that model unknown pta balloon dilatation catheter experienced a material deformation and crack. The information was received from a single source. The malfunction did not involve a patient. The male patient's age and weight were not provided.

• Brand Name: LITEPAC 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: 9955554
• MDR Text Key: 194124003
• Report Number: 9616666-2020-00033
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/13/2020

1 Device Was Involved in the Event

0 PatientS WERE 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: UNKNOWN LITEPAC
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage