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

Model Number	45027
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2021 as there were no information provided.
Event or Problem Description
It was reported that guidewire entrapment occurred.An angiojet zelantedvt was used for a thrombectomy procedure.During procedure, it was noted that the catheter would not track over the wire correctly and ended up getting stuck.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: used (b)(6) 2021 as there were no information provided.Device evaluated by mfr.: returned product consisted of an angiojet zelante catheter.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The shaft showed no damage.No guidewire was stuck in the device when returned.The guidewire lumen showed buckling damage 2cm from the tip.A.035 test guidewire was attempted to be inserted into the lumen; however, the wire would not transcend through the device.It showed that the guidewire lumen was punctured located 2cm from the tip.The supply line was severely kinked located 147.5cm from the pump body.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 of 11.370 kpsi.The device was run in the power pulse mode for a period of 60 seconds.During functional testing no errors or priming issues were noticed, the device ran as designed.No leaks at the pump area of the device were noticed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for guidewire lumen issues.
Event or Problem Description
It was reported that guidewire entrapment occurred.An angiojet zelantedvt was used for a thrombectomy procedure.During procedure, it was noted that the catheter would not track over the wire correctly and ended up getting stuck.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: 11783505
• Report Number: 2134265-2021-05791
• Device Sequence Number: 14367218
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 10/12/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0026254959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1