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

Model Number	10706
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the product was returned consisted of an angiojet spirolex catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.Functional testing was competed per the instructions for use device preparation.The pump was inserted into the ultra drive unit console.The catheter primed, and the device functioned for a period of 90 seconds in the thrombectomy mode.The device pressure was within the normal range.No leaks were observed during functional testing.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that an error message occurred.The target lesion was located in the coronary artery.An angiojet spiroflex catheter was selected for a thrombectomy procedure.During thrombectomy mode, liquid was observed leaking inside the pump portion of the machine and the console stopped all activity when prompted with an error message.The procedure was completed with a non-bsc device.No patient complications were reported.

• Brand Name: ANGIOJET SPIROFLEX
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16265509
• Report Number: 2124215-2023-02418
• Device Sequence Number: 17594256
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K072769
• 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): 01/30/2023

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: 10/16/2023
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0028556414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2021
• 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 Sex: Unknown