MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE GOGEAR SHOWER BAG; VENTRICULAR (ASSIST) BYPASS

Model Number	104232
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
Related mfr # 2916596-2023-06965, mfr # 2916596-2023-06966, mfr # 2916596-2023-07006, mfr # 2916596-2023-06967, and mfr #2916596-2023-06968.It was reported that the patient performed a controller exchange for red heart alarms after taking a shower.The patient claimed that their controller and battery clips had fluid ingress.
Additional Manufacturer Narrative
D4 - device serial/lot number was requested but was not provided.Manufacturer's investigation conclusion: the reported event of the battery clips and system controller getting wet after the shower was used was unable to be confirmed.The heartmate gogear shower bag (lot #: unknown) was not returned for analysis.No photos or additional documents were submitted for review.Multiple attempts were made to obtain additional information from the customer regarding if the patient was utilizing a shower bag; however, no additional information was provided.A root cause for the reported event was unable to be conclusively determined through this analysis.The heartmate 3 patient handbook, rev.D, section 4 ¿living with the heartmate 3¿ instructs users to not submerge the gogear shower bag in water.This section also explains how to properly use the shower bag.The heartmate 3 patient handbook, rev.D, section 6 ¿caring for the equipment¿ instructs users to periodically check all carrying equipment for damage.Users are advised to not used damaged products and to obtain a replacement by calling their hospital contact.Heartmate 3 patient handbook, rev.D, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ the lot number was not provided.This product is not serialized.The lot number is not printed on the product and is only available on the box/at the time the product is opened.This is not an out of box failure and the failure mode was not noticed at initial use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE GOGEAR SHOWER BAG
• 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: 17888891
• Report Number: 2916596-2023-07318
• Device Sequence Number: 6966507
• Product Code: DSQ
• UDI-Device Identifier: 00813024010456
• UDI-Public: 813024010456
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/08/2023

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: Lay User/Patient
• Device Model Number: 104232
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 134 KG