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

Model Number	45032
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned product consisted of the solent proxi thrombectomy catheter.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Visual inspection revealed numerous kinks throughout the device.Blood was present inside and 300ml of blood in the attached waste bag, when received.Functional testing was performed by placing the device in the angiojet ultra console and hooking up the device to the drip line and placing the tip into fluid then let the device sit for 60 seconds.There was no fluid that was released into the waste bag.The complaint device was then ran through the full priming cycle and 120 seconds in thrombectomy.The device ran within normal range, without any leaks from the device or any errors/alarms from the console.The device was also ran in power pulsed mode and no fluid was released into the waste bag.Inspection of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that aspiration occurred without activation.An angiojet solent proxi and angiojet ultra 5000a were selected for an arteriovenous fistula declot procedure in the patient's left arm.The devices were prepped in normal fashion with no issues of any kind.During the procedure, while the device was entering into the patient but before the device was activated, blood was noted to be coming out of the outflow line and into the waste bag.The angiojet was not activated when this occurred, and the foot pedal was not pressed.The physician proceeded to use the device, and it seemed to function normally, however it did not remove the localized clot from the vessel as they intended it to.Therefore the physician completed the procedure using a different device as it was thought that a different device would work better for this case.No further catheter issues were noted during the procedure.No patient complications were reported.The patient condition after the procedure was fine.

• 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: 8759736
• Report Number: 2134265-2019-07791
• Device Sequence Number: 16775067
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 07/03/2019

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: 03/23/2021
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0023883209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1