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

Model Number	100
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the driveline extension cable was not returned for evaluation.A review of the manufacturing documentation confirmed that the associated device met all requirements for release.Visual evidence provided revealed that the red dot guide was not printed on driveline extension cable connector.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed to an improper assembly during the manufacturing process.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.
Event or Problem Description
It was reported that during wet test the driveline extension cable was missing the red dot which indicates where to line it up with the ventricular assist device (vad) driveline cable.The driveline extension cable worked fine during wet test and has been exchanged.No patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE EXTENSION CABLE
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 12174918
• Report Number: 3007042319-2021-05360
• Device Sequence Number: 3298703
• Product Code: DSQ
• UDI-Device Identifier: 00888707000024
• UDI-Public: 00888707000024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: 100
• Device Catalogue Number: 100
• Device Lot Number: D000153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 59