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	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the aware date as no exact date provided.
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt catheter was selected for use in a thrombectomy procedure.However, during the procedure, it was noted that the catheter became stuck on the unknown wire.The catheter was removed from the patient's body along with the wire.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event - used the first day of the month of the aware date as no exact date provided.Device evaluated by mfr.: returned product consisted of the catheter portion of a zelante thrombectomy system with a guidewire inside the lumen.Only the catheter, hub, and portion of the effluent and supply lines were returned for analysis.The rest of the effluent and supply lines and pump assembly were not returned for analysis.The hub, shaft, hypotube, and tip were visually and microscopically inspected.Inspection of the device revealed that there was a lot of dried blood inside the hub and shaft, making it difficult to see the wire lumen, so the device was soaked for a few days in a warm water batch to loosen the dried blood.After soaking the device, a lot of the blood was removed, and it was noticed that the wire lumen was detached and buckled in the hub.The distal end of the separation was jagged, indicating that there was force applied causing the damage to the wire lumen.An attempt to remove the device from the wire was unsuccessful due to the damage to the device.As the wire was protruding from the hub and the tip, it was not possible to take an inner diameter of the zelante catheter, so the returned guidewire was measured and was confirmed to be a.035" wire.
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt catheter was selected for use in a thrombectomy procedure.However, during the procedure, it was noted that the catheter became stuck on the unknown wire.The catheter was removed from the patient's body along with the wire.The procedure was completed with another of the same device.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: 9787872
• Report Number: 2134265-2020-02535
• Device Sequence Number: 2456481
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: 11/26/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024964272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1