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

Model Number	45027
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a zelantedvt thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually and microscopically inspected.Inspection of the device revealed that the shaft was kinked 20cm distal of the strain relief.Microscopic examination of the hypotube at the location of the kink, revealed that the hypotube was broken.The separated ends of the hypotube were ovaled, indicating that the hypotube was kinked prior to the separation.Therefore; 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 the console to error and not work.
Event or Problem Description
Reportable based on device analysis completed on 22-april-2020.It was reported that an error message was displayed.An angiojet zelantedvt was used for a thrombectomy procedure in the left leg.During start of procedure while putting in the tissue plasminogen activator (tpa), multiple errors requesting alarm to be reset occurred in power pulse mode.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.However, device analysis revealed a hypotube break.

• Brand Name: ANGIOJET ZELANTEDVT
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10004611
• Report Number: 2134265-2020-05674
• Device Sequence Number: 2785136
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151313
• 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): 04/28/2020

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: 01/21/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0025163545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR