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

Model Number	45032
Medical Device Problem Codes	Leak/Splash (1354); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that loss of aspiration occurred.The target lesion was located in the leg.An angiojet solent proxi catheter was used for thrombectomy procedure.During the procedure, it was noted that the catheter was able to aspirate twice but unable to do so on the third time.Blood and fluid were noticed coming out from the bulb.The catheter was removed and prepped another angiojet solent proxi catheter.The catheter also aspirated thrombus a couple of times but then started leaking again.The procedure was completed with a non-bsc device.No patient complications were reported.
Event or Problem Description
It was reported that loss of aspiration occurred.The target lesion was located in the leg.An angiojet solent proxi catheter was used for thrombectomy procedure.During the procedure, it was noted that the catheter was able to aspirate twice but unable to do so on the third time.Blood and fluid were noticed coming out from the bulb.The catheter was removed and prepped another angiojet solent proxi catheter.The catheter also aspirated thrombus a couple of times but then started leaking again.The procedure was completed with a non-bsc device.No patient complications were 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 75ml of blood in the attached 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 and power pulse mode for 60 seconds.The device ran within normal range with no fluid leaking from the pump assembly or device or any errors/alarms from the console.When in power pulse mode there was no fluid that flowed into the waste bag.

• 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: 10288950
• Report Number: 2134265-2020-09459
• Device Sequence Number: 3462390
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/07/2020

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: 08/08/2021
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0024544116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1