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

Model Number	45027
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter became stuck on the guidewire and broke.The target lesion was located in the left iliac artery.An angiojet zelantedvt was used for a thrombectomy procedure.During the procedure, it was reported that the catheter became stuck on the non-bsc guidewire and broke.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a zelantedvt thrombectomy system with an unidentified.035" guidewire stuck in the lumen.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.There was blood present inside the device, when received.Inspection of the device revealed that the proximal and distal shafts were detached at the transition between the braided outer shaft and the clear outer shaft, 10.5cm proximal of the tip.The detached ends of the shaft were jagged.There were numerous kinks throughout the shaft was the distal shaft kinked at the distal window.The wire lumen was revealed to be buckled at the distal markerband for 1cm.The hypotube was noticed to be separated at the jet body with a shaft kink in the same location.The separated ends of the hypotube were ovaled, indicating that the hypotube was kinked causing the hypotube to separate.The damage to the shaft and hypotube, indicate there was force applied to the device causing the damage and separation.The id (inner diameter) of the tip was measured and the id tip and wire lumen were within specification.An attempt to remove the wire was made; however, the guidewire was unable to be removed due to the buckled wire lumen and was stuck in the zelante device.
Event or Problem Description
It was reported that catheter became stuck on the guidewire and broke.The target lesion was located in the left iliac artery.An angiojet zelantedvt was used for a thrombectomy procedure.During the procedure, it was reported that the catheter became stuck on the non-bsc guidewire and broke.No patient complications were reported.

• 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: 10219296
• Report Number: 2134265-2020-08695
• Device Sequence Number: 11571397
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/29/2020

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: 09/09/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024638381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIDEWIRE; GLIDEWIRE; GLIDEWIRE