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

Model Number	45030
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Difficult to Setup or Prepare (1487); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left lower leg artery.An angiojet solent dista catheter was used for thrombectomy procedure.However, the catheter would not prime and an error message occurred.The window on the console was cleaned but the catheter cannot be recognized nor prime.The catheter did not enter the patient's body but the patient was already sedated when the issue occurred and diagnostic catheter was already in the vessel.No other catheter was available so the procedure was aborted.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually inspected.Inspection presented no damage or irregularities to the pump assembly or the device.Functional testing was performed by placing the device in the angiojet ultra console.The barcode was able to be read instantly with no errors or difficulties and was able to go into prime mode.The complaint device ran through the full priming cycle and 120 seconds in thrombectomy mode.The device ran within normal range, without any issue, or leaks from the pump assembly or device and with no console errors/alarms.
Event or Problem Description
It was reported that the procedure was cancelled.The target lesion was located in the left lower leg artery.An angiojet solent dista catheter was used for thrombectomy procedure.However, the catheter would not prime and an error message occurred.The window on the console was cleaned but the catheter cannot be recognized nor prime.The catheter did not enter the patient's body but the patient was already sedated when the issue occurred and diagnostic catheter was already in the vessel.No other catheter was available so the procedure was aborted.No patient complications were reported.

• Brand Name: ANGIOJET SOLENT DISTA
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10374071
• Report Number: 2134265-2020-10591
• Device Sequence Number: 16924218
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K113363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0025449089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/26/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1