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

Model Number	425-3004X
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 device was not returned to bd for evaluation.The investigation is inconclusive for material rupture as the device was not returned.Based on the information provided, the definitive root cause is unknown.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 425-3004x pta dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient age, gender, and weight were not reported.

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9182923
• Report Number: 9616666-2019-00114
• Device Sequence Number: 14363294
• Product Code: LIT
• UDI-Device Identifier: 00801741132414
• UDI-Public: (01)00801741132414
• 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
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 425-3004X
• Device Catalogue Number: 425-3004X
• Device Lot Number: CMCV0196
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1