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

Model Number	10707
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	11/08/2021
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-left anterior descending artery.During preparation, after the patient was already sedated, the device was leaking at the pump assembly (where the connection for the back/priming tube meets the bulb), failed to prime, and there was an error message.There was no extra device to use so the procedure was cancelled.They needed to borrow a catheter from another facility, so the patient was rescheduled to be brought back to the cath lab the following day.No patient complications 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-left anterior descending artery.During preparation, after the patient was already sedated, the device was leaking at the pump assembly (where the connection for the back/priming tube meets the bulb), failed to prime, and there was an error message.There was no extra device to use so the procedure was cancelled.They needed to borrow a catheter from another facility, so the patient was rescheduled to be brought back to the cath lab the following day.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the product return contained an angiojet spiroflex.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed no signs of damage.A functional test was performed.The pump was placed 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.No damage or discrepancies were noted on the rest of the catheter upon visual inspection.

• Brand Name: ANGIOJET SPIROFLEX VG
• 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: 12867593
• Report Number: 2134265-2021-14523
• Device Sequence Number: 5748627
• Product Code: MCX
• UDI-Device Identifier: 08714729889441
• UDI-Public: 08714729889441
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080806
• 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
• 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: 06/30/2022
• Device Model Number: 10707
• Device Catalogue Number: 10707
• Device Lot Number: 0026039298
• 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): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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