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

Model Number	45030
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis on 02-mar-2022.It was reported that an error message occurred.An angiojet solent dista was used in a thrombectomy procedure.During the procedure, it was noted that an error message was displayed.The procedure was completed with a different device.There were no patient complications reported.However, returned device analysis revealed a hypotube break.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device returned to boston scientific for analysis.The product return contained an angiojet solent dista.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed no signs of damage.A functional test was performed.The pump was placed into the ultra drive console and the device displayed an under pressure error message.The device was unable to run, due to the pressure being below specifications.An x-ray inspection on the device revealed a break in the hyptube at 25cm from the tip.Functional testing confirms the presence of error messages.

• Brand Name: ANGIOJET SOLENT DISTA
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13897200
• Report Number: 2134265-2022-03315
• Device Sequence Number: 17159950
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K113363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: 09/12/2022
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0026376657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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
• Patient Sex: Unknown