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

Model Number	436-2512X
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review was performed.The sample and an image was returned for evaluation, and the investigation confirmed for device dislocation and device marking problem.A definite root cause for the reported event could not be determined.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 436-2512x otw pta catheter allegedly experienced device dislocation and device marking problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old male is unknown.

• Brand Name: SAVVY LONG 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: 10280769
• Report Number: 9616666-2020-00066
• Device Sequence Number: 2865271
• Product Code: LIT
• UDI-Device Identifier: 00801741132797
• UDI-Public: (01)00801741132797
• 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): 07/15/2020

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
• Operator of Device: No Information
• Device Model Number: 436-2512X
• Device Catalogue Number: 436-2512X
• Device Lot Number: CMDS0491
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Patient Sequence Number: 1