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

Model Number	45027
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter break occurred.The 100% stenosed target lesion was located in the non-calcified subclavian vein.An angiojet zelantedvt was advanced for thrombectomy procedure.Upon advancing towards the lesion, resistance was met.The physician stopped advancing and pulled the catheter back for approximately 1cm and attempted to advance again, but met some resistance again.When the physician removed the catheter, a fracture on the device was noted.The catheter was removed intact from the patient's body and the procedure was completed with another of the same device.No patient complications reported.
Event or Problem Description
It was reported, that a catheter break occurred.The 100% stenosed, target lesion was located in the non-calcified subclavian vein.An angiojet zelantedvt was advanced for thrombectomy procedure.Upon advancing towards the lesion, resistance was met.The physician stopped advancing and pulled the catheter back for approximately 1cm.And attempted to advance again, but met some resistance again.When the physician removed the catheter, a fracture on the device was noted.The catheter was removed intact from the patient's body.And the procedure was completed with another of the same device.No patient complications reported.
Additional Manufacturer Narrative
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 a severe kink.And a broken outer shaft 10.5cm from the tip.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.There was a leak at the 10.5cm location.During functional testing, no errors or priming issues were noticed.Inspection of the remainder of the device revealed, no 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: 11809937
• Report Number: 2134265-2021-06009
• Device Sequence Number: 14318014
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 07/07/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0025741126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR