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

Model Number	106528US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
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 skin punch was noted to be bent out of box, making it difficult to use during implant.The skin punch was still used but the surgeon expressed that it did not work well given the defect.The case was not prolonged as the surgeon was able to use an alternative method.There was no serious injury to the patient and the left ventricular assist device (lvad) was functioning as intended.
Additional Manufacturer Narrative
Section d4 and h4: expiration and manufacturing date was not available.Manufacturer's investigation conclusion: evaluation of the returned skin coring punch (6 mm (millimeters)) confirmed the bent blade.The skin coring punch was returned in like-new condition.Removal of the clear blade protector cap covering the skin punch revealed a visibly dented/dulled blade.A cut test was performed with the returned skin coring punch and a silicone mat.The skin coring punch was unable to cut through the silicone mat as expected, consistent with the reported event.A manufacturing analysis task was initiated to address an out of box bent skin coring punch.The skin coring punch is manufactured 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.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.There were no ncmrs (non-conformance material reports) or re-works related to the reported event.The heartmate 3 lvas ifu, rev.C, is currently available.Section 5 of this ifu contains instructions for creating the driveline exit site.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 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: 17318712
• Report Number: 2916596-2023-04673
• Device Sequence Number: 6188306
• Product Code: DSQ
• UDI-Device Identifier: 05415067030825
• UDI-Public: 05415067030825
• 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): 10/31/2023

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: 10/16/2024
• Device Model Number: 106528US
• Device Catalogue Number: 106524US
• Device Lot Number: 8613601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 57 KG