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

Model Number	426-2522X
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catalog number identified in section has not been cleared in the us, but is similar to the sleek otw pta catheter products that are cleared in the us.The pro code for the sleek otw pta catheter products is identified.The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was returned for evaluation.Investigation was unconfirmed for packaging issue and confirmed for the reported balloon damage.A definitive root cause has not been determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 426-2522x pta catheter allegedly experienced packaging problem, material deformation and detachment of device or device component.The information was received from one source.This event did not involve a patient as there was no patient contact.

• 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: 10279918
• Report Number: 9616666-2020-00062
• Device Sequence Number: 11394652
• Product Code: DQY
• UDI-Device Identifier: 00801741133701
• UDI-Public: (01)00801741133701
• 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: 426-2522X
• Device Catalogue Number: 426-2522X
• Device Lot Number: CMCQ0469
• 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