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

Model Number 114610-001

Device Problems Fluid/Blood Leak (1250); Failure to Prime (1492)

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

Event Date 03/20/2021

Event Type  malfunction  

Event Description

Patient developed deep vein thrombosis status post left knee arthroscopy with acl reconstruction.Patient was taken to interventional radiology for a mechanical thrombectomy.Per the staff, the device would not prime as saline was leaking in the chamber.The device was never used on the patient, but rather removed from the field and replaced.

• Brand Name: ANGIOJET ZELANTEDVT
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientic way; marlborough MA 01752 1235
• MDR Report Key: 11663583
• MDR Text Key: 245340658
• Report Number: 11663583
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 114610-001
• Device Catalogue Number: 114610-001
• Device Lot Number: 26288815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA