MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number	45032
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	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Model/lot numbers for all catheters used in this event: 45032/27805633 (2 catheters) and 45026/28613197 (2 catheters).
Event or Problem Description
It was reported that the procedure was cancelled and rescheduled, as all four catheters failed to complete the priming process.This angiojet solent proxi catheter was selected for a thrombectomy procedure to treat the clotted vessel.However, during the preparation, the device failed to complete the priming process.During troubleshooting, another angiojet solent proxi catheter and two angiojet avx catheters were also attempted unsuccessfully.All four catheters failed to prime and had an error code.The procedure was cancelled and rescheduled.No patient complications were reported, and the patient's status was stable.

• Brand Name: ANGIOJET SOLENT PROXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16817716
• Report Number: 2124215-2023-19296
• Device Sequence Number: 17923360
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• 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): 04/26/2023

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: 05/16/2023
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0027805633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown