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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet solent dista was used in a thrombectomy procedure.During preparation, it was noted that the device showed an error message and the catheter would not flush.As a result, the procedure was cancelled.There were no patient complications reported.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet solent dista was used in a thrombectomy procedure.During preparation, it was noted that the device showed an error message and the catheter would not flush.As a result, the procedure was cancelled.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device returned to boston scientific for analysis.The product return contained an angiojet solent omni.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device shaft showed one mild kink 47.5 cm from the tip on the catheter and a severe kink at the strain relief.A functional test was performed.The pump was placed into the ultra drive console but the device gave an over pressure error.The devices pressure was not within normal range.The pressure was over 14.000 kpsi.The hypotube was dissected at the strain relief, and confirmed the presence of a kink in the hypotube which was likely severe enough to cause an overpressure error.No leaks were noticed during functional testing.Inspection of the device aside from the observed damage revealed no additional damage to the device.

• 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: 12739647
• Report Number: 2134265-2021-13413
• Device Sequence Number: 19858455
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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: 12/12/2021
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0025328130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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