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

Model Number	45027
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of an angiojet zelantedvt catheter.The device arrived stuck on a guidewire.The assembly, supply line, shaft, tip, and spike line were all visually examined for potential damage.The device showed no signs of damage, however, observation of the device revealed some foreign material on the tip.To further investigate, the tip was dissected and the foreign material was found to be inside the dedicated guidewire lumen as well.An ftir investigation of the material was performed and showed the primary contents to most likely be gelatin foam and wool.A sheath insertion test was performed and confirmed the device inability to pass through the guidewire, with the tip being unable to pass through the catheter.
Event or Problem Description
Reportable based on device analysis completed on 01-september-2021.It was reported that the device would not enter sheath occurred.An angiojet zelantedvt catheter was used for thrombectomy procedure.However, during the insertion of device, the device would not enter the sheath when loaded on the guidewire.The procedure was completed.No patient complications were reported.However, returned device analysis revealed a foreign material on the tip.

• 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: 12508576
• Report Number: 2134265-2021-11287
• Device Sequence Number: 3067605
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/21/2021

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: 03/11/2023
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0027053792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1