MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF; VENTRICULAR (ASSIST) BYPASS

Model Number	105581US
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is completed.
Event or Problem Description
It was reported that the outflow graft began leaking during pump assembly.The same outflow graft was removed and replaced to rule out misconnection but leaking persisted at the connection point where the dacron meets the nut.
Event or Problem Description
There was a short delay while a new outflow graft was retrieved but no adverse event occurred.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned outflow graft confirmed the reported leaking.The outflow graft and outflow graft bend relief were returned in like-new condition.The bend relief was unremarkable.Visual inspection of the outflow graft in its returned state revealed areas of black mold that appeared to result due to the shipping and handling process used to return the graft to abbott for analysis; the graft was otherwise unremarkable.After a leak test was performed confirming the event, the outflow graft attachment hardware was removed.Visual inspection of the sewing threads revealed an area with a substantial through-hole as compared to the rest.A manufacturing analysis task was initiated to address the out of box leaking of the outflow graft during pump assembly.The sewing thread under the outflow graft attachment hardware is applied by abbott¿s supplier.A non-issuance external corrective action request was issued to the supplier for notification of the observed issue.No further action was required.Review of the relevant sections of the device history records for lot number 8590550 showed no deviations from the manufacturing and quality assurance (qa) specifications.There were no non-conformance material reports (ncmrs), or re-works related to the reported event.The heartmate 3 lvas instructions for use (ifu), rev.C is currently available.Section 5 of this ifu contains instructions for unpacking the sealed outflow graft (5-15) and preparing the sealed outflow graft (5-16).Section 5 also states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SEALED OUTFLOW GRAFT WITH BEND RELIEF
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16712988
• Report Number: 2916596-2023-01913
• Device Sequence Number: 1609511
• Product Code: DSQ
• UDI-Device Identifier: 00813024013266
• UDI-Public: 00813024013266
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: Health Professional
• Device Expiration Date: 08/23/2024
• Device Model Number: 105581US
• Device Catalogue Number: 105581US
• Device Lot Number: 8590550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 43 KG