MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3367-40QC

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Event Description

During a revision procedure to address a dislodged left ventricular lead, there was some blood noted on the header of the device.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

Upon receipt, the device was interrogated on a programmer and normal communication was established.Programmer printouts were obtained, and the device was decontaminated.After decontamination, a visual inspection of the device and torque wrench was performed and there was body fluid observed in the header of the device.The device header was inspected further under magnification and body fluid was observed in the right ventricular (rv) and left ventricular (lv) bores.The is4 and df4 septa were noted to be slightly damaged, which is consistent with procedural damage when multiple attempts to secure or disconnect the leads using a torque driver.This damage may result in body fluid contaminating the device header.The device was connected to test leads and resistor loads, and the high voltage lead impedance and pacing lead impedance were measured, and no anomalies were found.The device sensing was also tested, and the device was found to be normal.The reported event of body fluid in the header was confirmed, however the issue was found to be consistent with procedural damage.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 9720545
• MDR Text Key: 179751044
• Report Number: 2938836-2020-01300
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

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: 09/30/2021
• Device Model Number: CD3367-40QC
• Device Lot Number: P000088980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1