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

Model Number 10706

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/03/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 308575526
• Report Number: 2124215-2023-02418
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1