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

Model Number	426-1510X
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The one device belonging to the sole complaint is expected to be returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 426-1510x pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not reported.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned and material rupture was not confirmed.Based upon the available information, a definitive root cause is unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 426-1510x pta balloon dilatation catheter allegedly experienced a material rupture.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not reported.

• Brand Name: SLEEK OTW PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9182922
• Report Number: 9616666-2019-00116
• Device Sequence Number: 19475063
• Product Code: LIT
• UDI-Device Identifier: 00801741133541
• UDI-Public: (01)00801741133541
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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
• Operator of Device: No Information
• Device Model Number: 426-1510X
• Device Catalogue Number: 426-1510X
• Device Lot Number: CMCY0465
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1