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	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that catheter break occurred.An angiojet solent proxi was used for a thrombectomy procedure.However, it was noted that the catheter had cracked in multiple locations.The procedure was completed with another of the same device.No patient injuries or complications were reported.
Event or Problem Description
It was reported that catheter break occurred.An angiojet solent proxi was used for a thrombectomy procedure.However, it was noted that the catheter had cracked in multiple locations.The procedure was completed with another of the same device.No patient injuries or complications were reported.
Additional Manufacturer Narrative
B3: date of event - used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: returned product consisted of the solent proxi thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually and microscopically inspected.Blood was present inside the device and 400ml of blood in the attached waste bag, when received.Inspection of the device revealed that there were numerous kinks throughout the catheter shaft.Microscopic examination of the shaft revealed that at shaft had holes at the severe kinks 8.5cm, 36.4cm, 36.8cm, and 37.2cm distal of the strain relief.

• 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: 10009642
• Report Number: 2134265-2020-05731
• Device Sequence Number: 2897054
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/26/2020

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: 07/28/2021
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0024601468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1