MAUDE Adverse Event Report: ANGIOJET SOLENT OMNI; CATHETER, EMBOLECTOMY

Model Number	45031
Medical Device Problem Codes	Suction Problem (2170); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device returned contained an angiojet solent omni.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The catheter had multiple kinks along the catheter shaft.A functional test was performed.The pump was placed into the ultra drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product, with a pressure of 10.646 kpsi.There is no confirmation for the complaints allegation of shaft perforation or loss of aspiration.
Event or Problem Description
It was reported that loss of aspiration occurred.An angiojet solent omni catheter was used for the thrombectomy procedure.During the procedure, it was reported there was a hole in the shaft of the catheter causing diminished suction power.The device continued to pump saline when aspiration was lost and the procedure was completed successfully.No patient complications were reported.

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: CATHETER, EMBOLECTOMY
• MDR Report Key: 12744996
• Report Number: 2134265-2021-13194
• Device Sequence Number: 11882140
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 05/15/2023
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0027758153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1