MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM-DRIVELINE CABLE; VENTRICULAR (ASSISST) BYPASS

Model Number 1104

Device Problem Material Integrity Problem (2978)

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

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary: driveline cable (b)(4) was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Review of the controller log files could not be performed since log files covering the reported event date were not available for analysis.On-site inspection of the driveline cable revealed that the outer sheath was cracked, confirming the reported event.A driveline sheath repair was performed to mitigate the conditions reported.Based on the available information, the additional damage to the driveline was a progression of the previously reported damage.An internal investigation evaluated driveline sheath damages.Based on the investigation conducted, the most likely root cause of the driveline sheath damage is exposure to uv light.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient¿s driveline outer sheath was cracked in three areas.One was new and two had previously been repaired but the silicone was lifting.A driveline sheath repair was completed.There was no reported effect on the patient.The driveline remains in use.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM-DRIVELINE CABLE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7155805
• MDR Text Key: 96125087
• Report Number: 3007042319-2017-05521
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Date Device Manufactured: 09/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1751-2015
• Patient Sequence Number: 1
• Patient Age: 46 YR