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

Model Number 106524US

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that not only outer but inner cartons got damaged for 5 kits.Replacements were requested.No further information was provided.

Manufacturer Narrative

Section h1: correction.Section d10: additional information.Manufacturer's investigation conclusion: the report of damage to the outer shipping box and inner shipping box was confirmed.The implant kit was returned in the original shipping boxes.The outer shipping box showed damage to both of the longer sides of the box, as well as two small cuts on the top of the box and a scrape across the bottom of the box.The inner shipping box showed a dent on one of the long sides of the box corresponding to the damage to the side of the outer box.Additionally, there was a dent on one of the bottom corners of the box.There was no indication that the implant kit was affected by the damage.Review of the manufacturing documentation found no deviations from manufacturing or quality assurance specifications, including packaging and labeling inspection.The reported damage appeared to have occurred during shipment to the distributor, however, the specific root cause could not be determined.The heartmate 3 instructions for use (japan) indicates, in section 5 (surgical procedures), the steps to take in order to maintain sterility of the components.This section also warns not to use sterile components if the sterile packaging is compromised.In addition, section 5 (under "surgical considerations") warns 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.Section e "symbols" (under ¿description of labeling symbols¿) includes a description of the general symbol which indicates to not use if package is damaged.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9679568
• MDR Text Key: 178096741
• Report Number: 2916596-2020-00413
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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: Other
• Device Expiration Date: 07/08/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7319416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1