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

Model Number	45027
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Event or Problem Description
It was reported that guidewire entrapment and tip detachment occurred.After an amplatz guidewire was inserted, an angiojet zelantedvt was advanced for a thrombectomy procedure in the left common femoral, external iliac, and left common iliac veins.However, during procedure, the catheter tip became stuck on the guidewire and the catheter tip broke.The device shredded when going over the wire inside the sheath.The catheter and guidewire had to be removed together.The device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable and recovering from the procedure.

• 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: 9681847
• Report Number: 2134265-2020-01101
• Device Sequence Number: 3445350
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

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: 09/15/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024592349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1