MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS MINI APICAL CUFF KIT; VENTRICULAR (ASSISST) BYPASS

Model Number	10005877
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the white plastic apical cuff holder (the piece where the apical cuff attaches to the long handle) broke while trying to attach the mini cuff to myocardium.The patient was stable.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported damaged apical cuff holding tool was confirmed through the evaluation of the returned product.The apical cuff holding tool was returned in used condition.Examination of the returned apical cuff holding tool revealed that the handle was broken off from the apical cuff holding interface.The remainder of the device was unremarkable.The apical cuff holding tool was engaged to a test apical cuff and connected without issue.A specific cause for the damage to the apical cuff holding tool could not conclusively be determined through this evaluation.The device history records for the apical cuff holder lot #8034027 and apical cuff/tool kit lot #8029608 were reviewed.No deviations from manufacturing or quality assurance specifications were observed.This process includes visual inspection for physical damage at multiple steps throughout the fabrication process, including quality assurance final review.This issue was forwarded for manufacturing analysis.The manufacturing analysis did not find a specific root cause for the fracture on the apical cuff holding tool.A dhr review was performed and showed no observed instances of part cracking/damage nor any deviations from procedure.Additionally, multiple visual inspections are in place for the upstream apical cuff holding tool assembly, and there is no downstream processing within manufacturing that would have induced the observed damage.The heartmate 3 mini apical cuff kit ifu is currently available.The surgical procedures section of this ifu warns ¿do not use the device if it appears to be damaged in any way¿.This ifu also contains instructions for preparing the mini apical cuff and apical cuff holder, securing the mini apical cuff to the ventricle, and confirming hemostasis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Common Device Name: VENTRICULAR (ASSISST) 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: 12804502
• Report Number: 2916596-2021-06544
• Device Sequence Number: 5511503
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 07/14/2024
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 8029608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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 Sex: Female
• Patient Weight: 110 KG