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

Model Number	45031
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The shaft showed no damage.Functional testing was completed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed and ran as designed for 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.The device functioned as design with no abnormalities noticed.An aspiration test was performed by inserting the devices tip into a 100cc beaker.The device was activated, and the device removed fluid as designed.No leaks were noticed during functional analysis.Inspection of the remainder of the device damage, revealed no damage or irregularities.
Event or Problem Description
It was reported that loss of aspiration occurred.An angiojet solent omni catheter was used in a thrombectomy procedure.During the procedure, it was noted that the catheter would not perform thrombectomy and aspiration was lost while the device continue to pump saline.No patient complications were reported.

• Brand Name: ANGIOJET SOLENT OMNI
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11829328
• Report Number: 2134265-2021-05899
• Device Sequence Number: 4015590
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 12/29/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0026839292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1