MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ANGIOJET® ZELANTEDVT¿; CATHETER, EMBOLECTOMY

Model Number 114610-001

Device Problem Use of Device Problem (1670)

Patient Problems Air Embolism (1697); Anoxia (1711); Death (1802); Brain Injury (2219)

Event Type  Death  

Manufacturer Narrative

Event date: in the first week of (b)(6) 2016.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported air embolism occurred.The physician was performing a thrombectomy procedure in the pulmonary artery with a angiojet zelantedvt catheter.Contrast was injected through the side port of the hub.The physician believes that air was introduced into the thoracic space.The catheter was removed from the patient.There were no complications reported.

Manufacturer Narrative

Updated: outcomes attrib.To ae.Type of reportable event : corrected from serious injury to death.(b)(4).

Event Description

It was further reported the procedure was being performed in the large capacious pulmonary arteries and "the physician felt as the zelante would work the best".Air was visualized during imaging.The procedure was completed with a 6f solent omni ultra catheter.After the procedure the patient had an anoxic brain injury.Due to the anoxic brain injury, the patients family decided to withdraw care, subsequently, the patient expired.

• Brand Name: ANGIOJET® ZELANTEDVT¿
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5484251
• MDR Text Key: 39806407
• Report Number: 2134265-2016-01563
• Device Sequence Number: 1
• Product Code: DXE
• 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,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 114610-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death; Other