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

Model Number 10005877

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that when the mini apical cuff was opened the clear o-ring was discovered to be missing.This was discovered by a scrub nurse who removed the handle from the package, and upon placing it inside the mini apical cuff it came right back out.The box and package were inspected for the missing o-ring, however it was not found.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report that the apical cuff holding tool was missing its clear o-ring (sealing ring attachment), out-of-box, could not be confirmed through this evaluation.It was reported that when the mini apical cuff was opened onto the field, the scrub nurse removed the handle from the package and went to place it inside the mini cuff, and the handle came right out.When the scrub nurse held it up, it was observed that the o-ring was missing from the end of the holder.The handle was not used.The patient did not experience any adverse consequences related to this event, and will remain ongoing with routine care.Review of the device history records (dhr) for the apical cuff holding tool assembly showed no deviations from manufacturing or quality assurance specifications.The relevant shop order found that the steps for confirming orientation on the sealing ring attachment were successfully performed for each holding tool within the lot.Although a specific duration of time for which the sealing ring was missing could not be conclusively determined, it should be noted that this does not appear to be a manufacturing-related issue based on the dhr.The clinical specialist reported that no photos of the tool were available.It was reported that the apical cuff holder would not be returned for evaluation.Review of the device history records for the mini apical cuff kit, lot number 7803980, showed no deviations from manufacturing or quality assurance specifications.Review of the dhrs for the apical cuff holding tool assembly associated with this kit, for apical cuff holding tool lot number also showed no deviations from manufacturing or quality assurance specifications.Shop order found that the steps for confirming orientation on the sealing ring attachment were successfully performed for each holding tool within lot number, per fab.The heartmate 3 (hm3) mini apical cuff kit instructions for use (ifu) is currently available.The overview section of this ifu provides a description of the apical cuff holder, stating that a silicone o-ring is present at the interface of the circular disk and apical cuff, for a hemostatic connection with the apical cuff.This section also cautions the user to notify the appropriate thoratec personnel if there is a change in how the device works, sounds, or feels.Adverse events associated with the use of the mini apical cuff kit are also outlined; however, it should be noted that the patient did not experience any adverse consequences related to the current event.The surgical procedures section of the hm3 mini apical cuff kit ifu explains how to prepare the mini apical cuff and the apical cuff holder for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS MINI APICAL CUFF KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12221775
• MDR Text Key: 263439115
• Report Number: 2916596-2021-03653
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013082
• UDI-Public: 00813024013082
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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: Lay User/Patient
• Device Expiration Date: 01/22/2024
• Device Model Number: 10005877
• Device Catalogue Number: 10005877
• Device Lot Number: 7803980
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 10/04/2021
• Supplement Dates FDA Received: 10/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1