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

Model Number 45027

Device Problems Display or Visual Feedback Problem (1184); Difficult to Flush (1251)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device analysis by mfr: the 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 device returned with 300cc of blood in the waste bag.A kink was located 12cm from the tip.Functional testing was attempted.The pump was inserted into the ultra drive unit console.The pump and device would not prime.The devices pressure could not be recorded.The device was dissected at the kinked area and showed a small break in the hypotube.Upon manipulating the shaft to try and get an acceptable photo the hypotube separated due to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on device analysis result completed on 20may2021.It was reported that the device could not be flushed and an error message appeared.An angiojet zelantedvt catheter was selected for use in a thrombectomy procedure.The device was working fine, until the second time it was used, a check saline supply error message occurred, and the catheter could no longer be flushed.The procedure was completed and there were no patient complications reported.The patient was stable.However, returned device analysis revealed a 12cm kink from the tip and a small break in the hypotube.

• Brand Name: ANGIOJET ZELANTEDVT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11917386
• MDR Text Key: 254136905
• Report Number: 2134265-2021-06871
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0026868861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1