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); Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
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.The pump was placed into the ultra drive console but the device gave an under pressure error.The devices pressure was not within normal range.The cause of the over-pressure was further investigated.An x-ray test resulted in an inconclusive cause, so the jet head was removed and inspected.On microscopic inspection, it was found that a hole in the jet head was occluded.Further testing provided evidence that suggested the occlusion was a combination of gold and stainless steel.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that catheter failed to prime, pump assembly leaked and check saline error occurred.The target lesion was located in the femoral popliteal bypass artery.An angiojet solent dista was used in a thrombectomy procedure.During the procedure, it was noted that the catheter failed to prime, the pump assembly leaked and a check saline supply error message occurred.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a plugged jet hole.

• 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: 13958319
• Report Number: 2134265-2022-03587
• Device Sequence Number: 19880380
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 07/27/2023
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0028041972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Race: White