MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number	45032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.An angiojet solent proxi catheter was used for a thrombectomy procedure.However, during procedure, it was noted that the device broke.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the solent proxi thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually inspected.Inspection of the device presented no damage or irregularities.Blood was present inside the device and 100ml waste bag, when received.Functional testing was performed by placing the device in the angiojet ultra console.The testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy.The device ran within normal range with no fluid leaking from the pump assembly or device or any errors/alarms from the console.
Event or Problem Description
It was reported that a catheter break occurred.An angiojet solent proxi catheter was used for a thrombectomy procedure.However, during procedure, it was noted that the device broke.There were no patient complications reported.

• Brand Name: ANGIOJET SOLENT PROXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10465072
• Report Number: 2134265-2020-11849
• Device Sequence Number: 2889249
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 06/12/2022
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0025777959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1