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	02/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error message occurred.The target lesion was located in the coronary artery.An angiojet spiroflex was used in a thrombectomy procedure.During the procedure under thrombectomy mode, it was noted that a check saline supply error message occurred and saline was pooling at the base of the catheter pump.Another angiojet spiroflex was used but still the same issue occurred.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet spiroflex 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 attempted per the instructions for use.The pump was inserted into the ultra drive unit console.The pump and device primed and ran as designed for 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.The device functioned as design with no abnormalities noticed.No leaks were noticed during functional analysis.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 was used in a thrombectomy procedure.During the procedure under thrombectomy mode, it was noted that a check saline supply error message occurred and saline was pooling at the base of the catheter pump.Another angiojet spiroflex was used but still the same issue occurred.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
• MDR Report Key: 11603196
• Report Number: 2134265-2021-04022
• Device Sequence Number: 17195095
• Product Code: MCX
• UDI-Device Identifier: 08714729889380
• UDI-Public: 08714729889380
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 07/14/2022
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0026014240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1