MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT DISTA; CATHETER, EMBOLECTOMY

Model Number	45030
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a solent dista thrombectomy in two pieces.The pump, effluent/supply line, shaft, tip, piston, and spike line were microscopically and visually inspected.There was blood present in the device.Inspection of the device revealed that the shaft was detached 59cm distal of the strain relief.The shaft appeared to have been kinked/bent prior to separation.With the shaft separated, the hypotube would also be separated in the same location.When the hypotube is broken, the device will not prime and the console will continue to try and prime the catheter.This will cause the 'check saline supply' error to display on the console and the device not to prime.
Event or Problem Description
Reportable based on device analysis completed on 21-feb-2020.It was reported that device displays error message.After two angiojet solent dista catheters were used but failed the priming process, another catheter was advanced for a thrombectomy procedure.After the catheter was successfully primed, the catheter was put over the unknown wire and was introduced into the patient.However, the catheter would not function and check saline supply error occurred.The physician ended up infusing the patient overnight with a non-bsc device and going to look at it again the next day.No patient complications were reported.However, device analysis revealed a hypotube and shaft detachment/separation.

• Brand Name: ANGIOJET SOLENT DISTA
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9805137
• Report Number: 2134265-2020-02776
• Device Sequence Number: 18996098
• Product Code: DXE
• UDI-Device Identifier: 08714729889731
• UDI-Public: 08714729889731
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K113363
• 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): 03/09/2020

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: 12/14/2020
• Device Model Number: 45030
• Device Catalogue Number: 45030
• Device Lot Number: 0023290759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1