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

Catalog Number 68202087

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section has not been cleared in the us, but is similar to the sleek rx pta catheter products that are cleared in the us.The product classification code for the sleek rx pta catheter product is identified.The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation, therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the device.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 indicated that model 68202087 pta dilatation catheter allegedly experienced detachment of device or device component.This information was received from one source.The malfunction did not involve a patient.The weight of the (b)(6) male patient was not provided.

• Brand Name: LITEPAC RX PTA CATHETER
• Type of Device: PTA 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: 9955416
• MDR Text Key: 195260397
• Report Number: 9616666-2020-00027
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391509837514
• UDI-Public: (01)05391509837514
• 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: 04/13/2020

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: 68202087
• Device Lot Number: CMCZ0159
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1