MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SPIROFLEX VG; CATHETER, EMBOLECTOMY

Model Number	10707
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an error message occurred.An angiojet spiroflex catheter was selected for use.During thrombectomy, an error message appeared which displayed "check flush bag/no flow".This occurred after 4 seconds of active use.A new angiojet spiroflex catheter was selected for use.During thrombectomy while inside the patient, the same error coded appeared.They were no visible defects noted on either device.The procedure was completed, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by the manufacturer.The device was returned for analysis.Returned product consisted of a spiroflex thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually inspected.Blood was present inside the device and in the attached waste bag.Inspection of the device revealed numerous kinks in the shaft.At a severe kink 29cm proximal of the tip, the hypotube was found to be broken.The separated ends of the hypotube were ovaled, indicating that the device was kinked prior to separation.The shaft was kinked causing the hypotube to break, when the hypotube is broke, the device will not prime and the console will continue to try and prime the catheter, causing 'check saline supply' error to display on the console.Product analysis confirmed the reported event, due to the hypotube being broken causing the device not to prime.
Event or Problem Description
It was reported that an error message occurred.An angiojet spiroflex catheter was selected for use.During thrombectomy, an error message appeared which displayed "check flush bag/no flow".This occurred after 4 seconds of active use.A new angiojet spiroflex catheter was selected for use.During thrombectomy while inside the patient, the same error coded appeared.They were no visible defects noted on either device.The procedure was completed, and no patient complications were reported.

• Brand Name: ANGIOJET SPIROFLEX VG
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9968686
• Report Number: 2134265-2020-05142
• Device Sequence Number: 4482996
• Product Code: MCX
• UDI-Device Identifier: 08714729889441
• UDI-Public: 08714729889441
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K080806
• 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): 05/04/2020

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: 09/07/2021
• Device Model Number: 10707
• Device Catalogue Number: 10707
• Device Lot Number: 0024856692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1