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

Catalog Number 1104

Device Problems Break (1069); Loose or Intermittent Connection (1371); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 01/22/2013

Event Type  Injury  

Manufacturer Narrative

The hvad is used for treatment not diagnosis.The driveline cable ((b)(4)) was not returned to manufacturer for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Review of controller log files was not possible as log files were not available for analysis.On-site inspection of the driveline cable revealed damage of the driveline cable, and poor connection of wires to a connector block installed as a bridge during a previous splice repair, thus confirming the reported event.Subsequently, another splice repair was performed to repair the wires and the driveline cable.It was further noted that the patient previously had two other slice repairs and was reported to damage the splice repairs performed on site.Information provided by the user facility indicated that this event involved a patient who intentionally damaged his/her own driveline.The root cause for the reported driveline splice damage can be attributed to inadequate splice design specifications that does not account excessive pull force that may be exerted on to the driveline cable, causing the splice pins to recess and interrupt pump operation.The manufacturer has an open internal investigation for damage to the splice kit.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, including transportation.The instructions for use (ifu) provides driveline care instructions to the clinician for inspecting the driveline for damage to the polyurethane outer tubing (outer sheath).The ifu and patient manual provide general care instructions on cleaning of the driveline, preventing damage to the polyurethane outer tubing (strain relief recessed out of connector).Prevention of damage and inspection of driveline information is also covered during patient and medical personnel training.Heartware is submitting this correction to a previously submitted mdr report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.

Event Description

It was reported that the vad coordinator on tuesday ((b)(6) 2013) was informed about a patient with a driveline damage.It was stated that the patient had already two splice repairs in the past.It was further stated that the vad coordinator highly suspect he is intentionally damaging the driveline.Manufacturer representative perform a "first aid" repair to regain device operation.Patient was then transfer to another hospital.During his stay there the patient reopened five times the plastic tube of the splice repair.On thursday ((b)(6) 2013) manufacturer representative took a look at the situation and made several pictures of the first aid repair and recognized a poor connection of the wires with the white connector block.At the same day we performed a splice repair with surgical backup.The physician was informed about the likely upcoming problems due to the poor connection of the wires (longer pump off time, if single stator operation will fail).The repair procedure started with cutting the wires of the rear motor.As warned the single stator operation failed.Proceeded with the procedure, finished rear wires and tried to restart pump in single stator operation and failed.Finished front wires to restart in dual stator mode.Pump did not restart correctly (over 25w and 400rpm).Rechecked everything, reconnected and restarted the pump and the pump started in dual stator mode.It was stated that the pump off time due to technical issues was 12 minutes.The clinic requested a solution to prevent the reopening of the white plastic tube by the patient.Physician consented to the use of epoxy and a thread locker to prevent reopening.This event involved a patient who intentionally damaged their own driveline.The site has specifically stated that the event is not a complaint and there is no allegation of device deficiency.No additional information available.

• Brand Name: HEARTWARE® VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 5992708
• MDR Text Key: 56096935
• Report Number: 3007042319-2016-03423
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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): Hospitalization; Required Intervention