MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SKIN CORING PUNCH (6 MM); VENTRICULAR (ASSIST) BYPASS

Model Number	106528US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
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 ventricular assist device (vad) team expressed concern that using the skin coring punch could potentially be creating a larger area than needed around the driveline, and could potentially be contributing to prolonged exit site healing.The vad team moving forward would no longer use the skin coring punch and would use a scalpel in its place.
Additional Manufacturer Narrative
Section a3: patient gender was not provided.Sections d4, h4: skin coring punch manufacture date and expiration date could not be provided.Manufacturer's investigation conclusion: the account¿s concern of the heartmate 3 skin coring punch creating a larger area than needed around the driveline and potentially prolonging exit site healing could not be conclusively determined through the evaluation of the provided image.No alarms, clinical symptoms, or ventricular assist device (vad)-related functional issues were reported in association with the event.The patient remains ongoing on ventricular assist device support.No product was returned for evaluation.Per hospital policy, no further information regarding the event will be provided by the account.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.Heartmate left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available and contains the following information: the ifu lists the skin coring punch (6 mm) as an optional component for device implantation in section 1, ¿introduction,¿ under ¿required, backup, and optional components and equipment¿.Section 5, entitled ¿surgical procedures¿, provides information on creating the driveline exit site.The ifu also warns that a complete backup system 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 SKIN CORING PUNCH (6 MM)
• 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: 17560396
• Report Number: 2916596-2023-05869
• Device Sequence Number: 3600230
• Product Code: DSQ
• UDI-Device Identifier: 05415067039361
• UDI-Public: 05415067039361
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 01/10/2025
• Device Model Number: 106528US
• Device Lot Number: 8757003
• Was Device Available for Evaluation?: No
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 10/26/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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: 51 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG