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

Model Number 426-2522X

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976); Packaging Problem (3007)

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 otw pta catheter products that are cleared in the us.The pro code for the sleek otw pta catheter products is identified.The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was returned for evaluation.Investigation was unconfirmed for packaging issue and confirmed for the reported balloon damage.A definitive root cause has not been determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 426-2522x pta catheter allegedly experienced packaging problem, material deformation and detachment of device or device component.The information was received from one source.This event did not involve a patient as there was no patient contact.

• 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: 10279918
• MDR Text Key: 202228898
• Report Number: 9616666-2020-00062
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741133701
• UDI-Public: (01)00801741133701
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 426-2522X
• Device Catalogue Number: 426-2522X
• Device Lot Number: CMCQ0469
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1