MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55118
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
The device was discarded by the customer and, therefore, a physical investigation could not be performed to determine the exact root cause.No patient impact or injury was reported in association with this event as the missing radiopaque tip was noticed prior to insertion of the catheter.Another catheter was used in the case.No definitive root cause could be identified.Review of the device history record indicated that the product was manufactured according to specification and met all acceptance criteria prior to release.There have been no other reported complaints from devices of the same lot.If additional information is received, a follow up report will be submitted.
Event or Problem Description
On 27 december 2019, ekos rep was informed that they had a catheter "that broke" during a pe case last week.The account placed another catheter and completed the case with no issue.The customer explained that prior to insertion, the radiopaque tip was in place but then fell off before the catheter could be used on the case.They pulled another catheter and worked fine.The patient had a good outcome.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 9598303
• Report Number: 3001627457-2020-00002
• Device Sequence Number: 2696660
• Product Code: KRA
• UDI-Device Identifier: 00858593006141
• UDI-Public: 00858593006141
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 500-55118
• Device Catalogue Number: 500-55118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1