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

Model Number	45027
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt catheter was used for a thrombectomy procedure.During the procedure, it was noted that the catheter was stuck on wire.The wire was changed but same issue occurred.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a zelantedvt thrombectomy system.The pump assembly, effluent/supply line, shaft, and tip were visually inspected.Blood was present inside the device and there was a mixture of blood and fluid in the attached waste bag, when received.Inspection of the device presented no damage or irregularities.Functional testing was performed by attempting to remove the guidewire from the zelante device.The guidewire was able to be removed from the hub with no issues.The wire was then reinserted through the hub and advanced through the device and removed once more with no issues.The inner diameter of the hub and tip was measured with a calibrated pin gage set.The pin gage was able to be placed into the device with no issues, indicating the id of the device was within specification.
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt catheter was used for a thrombectomy procedure.During the procedure, it was noted that the catheter was stuck on wire.The wire was changed but same issue occurred.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

• 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: 10810264
• Report Number: 2134265-2020-15421
• Device Sequence Number: 14497444
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: 04/18/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0023849116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1