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

Model Number 104232

Device Problem Mechanical Problem (1384)

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

Event Date 04/10/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the bag was leaking water.The team could not provide any further information.

Manufacturer Narrative

Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.Manufacturer's investigation conclusion: the report of fluid ingress into the heartmate gogear shower bag could not be confirmed through this evaluation as the product was not returned for evaluation.The account reported that the patient's shower bag was leaking water.A warranty replacement was requested by the account, and the leaking heartmate gogear shower bag was disposed of.Additional information regarding the event was requested from the account; however, they communicated that they cannot provide any additional details.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas) support with no further reported issues at this time.The lot number was not provided.This product is not sterilized.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.The heartmate 3 left ventricular assist system instructions for use (rev.C) and heartmate 3 left ventricular assist system patient handbook (rev.D) state in the caring for wear and carry accessories sections that wear and carry accessories should be periodically inspected for damage or wear.If an accessory appears damaged or worn, do not use it.Call your hospital contact for a replacement.The instructions for use and patient handbook also provide instructions on using and assembling the shower bag.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG
• Type of Device: 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19204294
• MDR Text Key: 341301911
• Report Number: 2916596-2024-02368
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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 Model Number: 104232
• Device Catalogue Number: 104232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 84 KG