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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE APICAL CORING KNIFE; VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE APICAL CORING KNIFE; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1050
Device Problem Dull, Blunt (2407)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2024
Event Type  malfunction  
Event Description
It was reported that the surgeon was unable to complete the coring of the ventricle with the coring knife.Coring was completed with scissors.The surgeon noted that it was fine at the start, but it didn't cut all the way through.The surgeon stated that there was no scarring or calcium in the way that could have hindered coring.The coring knife was fine for about three quarters of the way then scissors had to be used to finish coring.There were no patient consequences or delay in surgery as a result of the event.
 
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned coring knife could not confirm the reported event of cutting difficulty.A specific cause for the reported event could not be conclusively determined.The coring knife, serial number (b)(6), was returned with the protective blade plastic caps on each end.The coring knife handle was not returned.The coring knife was in used condition with blood residue present on the external and internal body, as well as the blade edge.Microscopic inspection of the coring knife found minor imperfections in the blade edge as well as an area of the blade edge with a rolled edge and a hanging burr.The remainder of the blade edge appeared largely unremarkable.A specific cause for the imperfections in the blade edge could not be conclusively determined, and it was unknown if the imperfections were present prior to knife handling or use.A cut test was performed with the returned coring knife and a foam sheet.The coring knife completely cut through the foam sheet without resistance.Review of manufacturing documentation found no deviations from manufacturing or quality specifications.Although the reported event could not be reproduced during the evaluation of the returned coring knife, a capa was opened to further investigate issues related to the coring knife not being able to cut.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.C, is currently available.Section 1, "introduction," lists the apical coring knife as an optional component for device implantation.Section 5, ¿surgical procedures,¿ provides information on preparing and handling the coring knife.This section 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.
 
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Brand Name
HEARTMATE APICAL CORING KNIFE
Type of Device
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
lindsey sallese
6035 stoneridge drive
pleasanton, CA 94588
7818528207
MDR Report Key18861302
MDR Text Key337676007
Report Number2916596-2024-01467
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024010227
UDI-Public00813024010227
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/22/2024
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
Device Operator Health Professional
Device Model Number1050
Device Lot Number10108295
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/04/2024
Initial Date FDA Received03/07/2024
Supplement Dates Manufacturer Received04/19/2024
Supplement Dates FDA Received04/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient SexMale
Patient Weight106 KG
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