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

Model Number 45027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802)

Event Date 09/22/2020

Event Type  Death  

Manufacturer Narrative

Age at time of event: over 18.

Event Description

It was reported that the patient passed away.An angiojet zelante catheter was selected for use in a thrombectomy procedure.A venogram showed a non-boston scientific inferior vena cava (ivc) filter with considerable clot burden in the common iliac and ivc.The angiojet zelante catheter was used for 90 seconds in thrombectomy mode.There was no tpa administered during the angiojet procedure.The results were good with increased flow.The physician then attempted to retrieve the ivc filter for the next two hours.There was no change in the patient condition during this time.Upon filter removal, it was noted by the staff that segments of the filter remained or had possibly broken off during removal.A non-boston scientific balloon was inflated in the ivc at which time the blood pressure dropped and went into cardiac arrest.After numerous attempts to revive the patient, a pulse was not established, and the patient passed away.The physician's opinion was that the patient suffered a pulmonary embolism after removal of the ivc filter.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10684919
• MDR Text Key: 211520099
• Report Number: 2134265-2020-14182
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATLAS BALLOON; BARD IVC FILTER
• Patient Outcome(s): Death