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); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet spiroflex catheter was selected for a patient left heart catheterization to treat a large thrombus in the mid lad coronary artery.The target lesion was located in the mid-left anterior descending artery.During preparation, after the patient was sedated, the device was leaking at the pump assembly (where the white collar meets the bulb) and the catheter failed to prime.There was an error message.There was no extra device to use.The procedure was not completed and the patient had to be transferred to another facility for another attempt of the procedure.No patient complications were reported.
Additional Manufacturer Narrative
H3: device return to manufacturer? corrected from "no" to "yes.".
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet spiroflex catheter was selected for a patient left heart catheterization to treat a large thrombus in the mid lad coronary artery.The target lesion was located in the mid-left anterior descending artery.During preparation, after the patient was sedated, the device was leaking at the pump assembly (where the white collar meets the bulb) and the catheter failed to prime.There was an error message.There was no extra device to use.The procedure was not completed and the patient had to be transferred to another facility for another attempt of the procedure.No patient complications were reported.Were reported.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet spiroflex catheter was selected for a patient left heart catheterization to treat a large thrombus in the mid lad coronary artery.The target lesion was located in the mid-left anterior descending artery.During preparation, after the patient was sedated, the device was leaking at the pump assembly (where the white collar meets the bulb) and the catheter failed to prime.There was an error message.There was no extra device to use.The procedure was not completed and the patient had to be transferred to another facility for another attempt of the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device returned containing an angiojet spiroflex.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed multiple kinks along the catheter.A functional test was performed by placing the pump into the ultra-drive console and the device primed with no complication.The device was run for a total time of 90 seconds in thrombectomy mode.The device stayed within the expected range of the product with average pressure.No damage or discrepancies were noted on the rest of the catheter upon visual inspection.H3: device return to manufacturer? corrected from "no" to "yes.".

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12863877
• Report Number: 2134265-2021-14454
• Device Sequence Number: 1520306
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 10/19/2022
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0026568482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 11/09/2021; 12/01/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 11/24/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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: Male
• Patient Race: Black Or African American