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

Model Number UNK-SHOULDER PACK

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the shoulder strap's hook, was damaged.The shoulder pack was not available for evaluation.A review of the manufacturing documentations could not be performed since the lot number of the shoulder pack was not provided.Applicable risk documentation and experience with events of similar circumstances were considered; events with damaged clips or snap hooks can be attributed to deterioration and/or due to the handling of the pack.The unit, however, was not available for analysis.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.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.If information is provided in the future, a supplemental report will be issued.

Event Description

A report was received that there was a loose hook on the shoulder pack strap causing the patient to drop the bag.The patient placed the strap of the bag across shoulder and stood up but somehow the hook of the shoulder strap disengaged from the bag resulting in the drop.The patient caught the bag in time and did not report feeling a pull of the driveline cable.This was the third incident that the hook came loose and disengaged from the bag.Although the patient¿s parents reinforced the bag with a cable tie, it would still slip through.The patient¿s parents also have replaced the cable tie with larger ones to reinforce the attachment to the bag.They have explored outdoor climbing hooks which appeared to be more durable but are concerned of the added weight for the patient.The patient was assessed for trauma to the driveline and exit site but none was found.The shoulder pack was removed from service and replaced with no reported patient consequence.A photo of the shoulder pack appears to confirm the event.No further information has been provided.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7075781
• MDR Text Key: 94109101
• Report Number: 3007042319-2017-04402
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-SHOULDER PACK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1