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

Model Number	425-3006X
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The result of the investigation is confirmed for the failure to cross the lesion issue reported.The definitive root cause for the reported failure to cross the lesion issue could not be determined based upon available information.The evaluation observed two kinks and a number of bends on the shaft.As it was reported that the catheter allegedly failed to cross a calcified and occluded right anterior tibial artery lesion, patient factors may have been the likely issue that contributed in the reported event and the catheter kinks.It is unlikely that the kinks are manufacturing related as a 100% visual inspection for catheter kinks is performed.The manufacturing documentation was reviewed and shows no anomalies with the manufacture of this lot to suggest a product issue.Finally it is unknown whether handling or procedural techniques contributed to the reported event.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 425-3006x sleek rx pta catheter allegedly failed to cross the lesion in a calcified and occluded anterior tibial artery.This malfunction involved one patient with no reported patient injury.This information was received from one source.The patients age, weight, and gender 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 ; EI
• MDR Report Key: 8817251
• Report Number: 9616666-2019-00086
• Device Sequence Number: 457060
• Product Code: LIT
• UDI-Device Identifier: 00801741132421
• UDI-Public: (01)00801741132421
• 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): 07/23/2019

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: 425-3006X
• Device Catalogue Number: 425-3006X
• Device Lot Number: 50126830
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1