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

Model Number	436-2022L
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported information, the devices were returned to bd and evaluated.The result of the investigation is confirmed for the detachment issue reported.The outer was detached from the balloon at the proximal bond.There was a break also observed on the inner and it appeared that a section of the inner was missing.The definitive root cause for the reported detachment issue could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model 436-2022l pta dilatation catheter allegedly experienced a break and detachment.This information was received from one source.The malfunction involved a patient with no known impact to the patient.Patient age, weight, and gender were not provided.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8783147
• Report Number: 9616666-2019-00076
• Device Sequence Number: 14119862
• Product Code: LIT
• UDI-Device Identifier: 00801741132742
• UDI-Public: (01)00801741132742
• 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): 07/11/2019

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: 436-2022L
• Device Catalogue Number: 436-2022L
• Device Lot Number: CMCV0276
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1