MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE® VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE

Catalog Number 1104

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.The instructions for use (ifu) provides an instruction and also a caution note about regular inspections of the driveline, specifically stating: "when changing your exit site dressing, inspect the driveline for moisture, cracks, and tears or punctures.Report any damage to your doctor, nurse or vad coordinator." it also cautions, "keep extra driveline length tucked under clothing or secured with an abdominal binder or dressing.Do not let any portion of driveline hang freely where it might get caught on external items such as doorknobs or the corners of furniture." (b)(4) was not returned to heartware for evaluation.Review of the manufacturing records confirmed that the associated driveline met all requirements for release.Onsite inspection revealed that the patient had completely cut through the driveline cable when attempting to remove his driveline exit site dressing.The patient experienced a pump off time of approximately 90 minutes.As per fs0011, a splice repair was out of scope due to the distance between the exit site and the remaining length of driveline.Dr.(b)(6) agreed to perform a temporary splice repair.The outer sheath and inner lumen was removed as well as the wires stripped and crimped.The crimped wires were then inserted into the contact block of splice kit 20 inch cable.The contact block and driveline were covered with rescue tape and the pump was restarted successfully.There is no evidence to suggest a device malfunction caused or contributed to the reported event.The most likely root cause of the damage to the driveline and pump stop was the patient cutting his driveline with scissors when attempting to remove his driveline exit site dressing.The manufacturer will submit a supplemental report when new facts arise which materially alter information submitted in a previous mdr report.

Event Description

It was reported that the patient accidently cut his driveline, during dressing change; the cut was approximately 3cm from the exit site.The action performed was a regular splice repair because of the remaining length of the driveline(3cm).The physician agreed to perform a temp splice repair, outer sheath was removed, inner lumen removed, wires have been stripped and crimped.The crimped wires have been inserted into the contact block of splice kit 20 inch cable.The contact block and driveline was covered with rescue tape; the pump was restarted successfully.The plan at the time was for the physician to expose the driveline next on (b)(6) 2016, so that the splice repair could be completed on this day.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 5987424
• MDR Text Key: 56003362
• Report Number: 3007042319-2016-03436
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1