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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt was used for a thrombectomy procedure.However, it was noted that the catheter would not move back and forth over the wire.No patient complications were reported.
Event or Problem Description
It was reported that catheter stuck on guidewire occurred.An angiojet zelantedvt was used for a thrombectomy procedure.However, it was noted that the catheter would not move back and forth over the wire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an angiojet zelante catheter.A.035 guidewire was stuck in the device when returned.The pump assembly, effluent/supply line, shaft, tip and spike line were visually examined for damage or any irregularities.The outer shaft showed no damage.A.035 guidewire was stuck in the device.The wire was protruding from the distal end approximately 18cm and protruding from the proximal end approximately 123.5cm from the hub.Functional testing was completed per device preparation.The pump was inserted into the ultra drive unit console.The pump and the device primed and were run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.During functional testing no errors or priming issues were noticed, the device ran as designed.The guidewire was attempted to be removed; however, the wire could not be pulled from the catheter lumen.It was noticed during microscopic analysis the dedicated guidewire lumen was separated at the distal end of the catheter shaft.The hub of the device was pulled apart and the proximal end of the guidewire lumen showed buckling.Inspection of the remainder of the device, apart from the observed guidewire lumen damage revealed no other damage or irregularities.

• 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: 11308106
• Report Number: 2134265-2021-01474
• Device Sequence Number: 3384364
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 08/11/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0025957148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1