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

Model Number	426-2010X
Medical Device Problem Codes	Break (1069); Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation reported issue was confirmed for a component missing, detachment and break.Based upon the available information, the definitive root cause for this event 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 426-2010x pta balloon dilatation catheter allegedly experienced component missing, detachment and break.This information was received from one source.The alleged failure mode had no patient involvement.Age, weight, and gender of the patient was not provided.

• 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: 10283327
• Report Number: 9616666-2020-00070
• Device Sequence Number: 689376
• Product Code: DQY
• UDI-Device Identifier: 00801741133596
• UDI-Public: (01)00801741133596
• 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): 07/16/2020

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: 426-2010X
• Device Catalogue Number: 426-2010X
• Device Lot Number: CMCP0040
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1