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

Model Number	426-1510X
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The balloon rupture was unconfirmed for the device.The device was labeled for single use.A root cause has not been 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 426-1510x.Otw pta catheter allegedly experienced material rupture, and stretched.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: SLEEK OTW PTA CATHETER
• Common Device Name: OTW PTA CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9182955
• Report Number: 9616666-2019-00119
• Device Sequence Number: 2693219
• Product Code: LIT
• UDI-Device Identifier: 00801741133541
• UDI-Public: (01)00801741133541
• 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 an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 426-1510X
• Device Catalogue Number: 426-1510X
• Device Lot Number: CMCX0056
• 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