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

Model Number	436-3015X
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation; therefore, the investigation is inconclusive for the retraction problem, as no objective evidence has been provided to confirm any alleged deficiency with the otw pta catheter.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the events indicated that model 436-3015x otw pta catheter experienced a retraction problem.This report was received from one source.The device was used in the patient.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The device was returned for evaluation and the investigation is inconclusive for the retraction problem, but confirmed for a break, material deformation and detachment.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4, h2, h6(device (b)(4).
Event or Problem Description
This report summarizes one malfunction.A review of the events indicated that model 436-3015x otw pta catheter experienced a retraction problem.This report was received from one source.The device was used in the patient.Patient age, weight, and gender were not provided.

• Brand Name: SAVVY LONG 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: 8783211
• Report Number: 9616666-2019-00080
• Device Sequence Number: 11429359
• Product Code: LIT
• UDI-Device Identifier: 00801741132940
• UDI-Public: (01)00801741132940
• 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,Followup
• Report Date (Section B): 03/30/2020

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: 436-3015X
• Device Catalogue Number: 436-3015X
• Device Lot Number: CMCV0428
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1