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

Model Number	426-1508X
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, a lot number was provided, and lot history reviews was performed.The device were returned to bd for evaluation.After further evaluation, the investigation is confirmed for the reported failure to advance issue.Additionally, material rupture, material deformation and stretched material were identified.The device was used off-label.However, based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported malfunction indicated that model 426-1508x pta balloon dilatation catheter allegedly experienced material rupture, material deformation, failure to advance and it was stretched.This report was received from one source.This malfunction involved a patient with no patient consequence's.Age, gender and weight was not provided for the reported patient.

• 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: 9582938
• Report Number: 9616666-2020-00005
• Device Sequence Number: 16280248
• Product Code: LIT
• UDI-Device Identifier: 00801741133534
• UDI-Public: (01)00801741133534
• 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): 01/13/2020

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: 426-1508X
• Device Catalogue Number: 426-1508X
• Device Lot Number: CMDU0005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1