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

Model Number	104232
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
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 there was a suspected leakage of the shower bag.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the returned gogear shower bag could not confirm the reported event of fluid ingress.A specific cause for the reported event could not be conclusively established through this evaluation.The shower bag was returned in new condition.The bag seams, zippers, and fabric appeared intact with no visible damage.The shower bag was mounted in a sink and water was poured onto the bag for over 15 minutes.The bag was visually inspected after 15 minutes did not reveal any evidence of a fluid ingress issue.The bag condition appeared unremarkable, and no damage was observed.The patient remains ongoing on heartmate 3 left ventricular system (lvas) support with no further related issues reported at this time.The device history records were reviewed and the records revealed that the heartmate gogear shower bag, lot # 10137953, was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.A, and the heartmate ii patient handbook, rev.C, are currently available.These documents 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 ifu explains that although the external components of the heartmate 3 lvas (including the shower bag) are moisture-resistant, they are not waterproof.The ifu warns that the shower bag must dry completely between uses.After showering, the exterior should be wiped with a clean, dry towel and the bag should be allowed to drip dry completely before being used again.The ifu 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
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21143617
• Report Number: 2916596-2024-53012
• Device Sequence Number: 9330216
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: (01)00813024011149(10)10137953(11)240108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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
• Device Catalogue Number: 104232
• Device Lot Number: 10137953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 62 KG