MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE GOGEAR WEARABLE ACCESSORIES KIT; VENTRICULAR (ASSISST) BYPASS

Model Number	106129
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the inside of shower bag got wet after taking a shower.
Additional Manufacturer Narrative
This event occurred at national cerebral & cardiovascular ctr.In osaka, japan.Section a: privacy laws in the event country prohibit sharing identifying patient information.Patient information should have been removed from the initial report.Manufacturer's investigation conclusion: the report of water ingress into the patient¿s shower bag could not be confirmed as the product was not returned for evaluation and no images of the reported event were provided.No alarms were reported for this event.A no-charge replacement bag was ordered.It was later reported that the hospital could not find the shower bag anymore.The patient remains ongoing on ventricular assist device (vad) support and no further issues have been reported.The hm3 ifu and hm3 patient handbook 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 and patient handbook also provide instructions on using and assembling the shower bag.Review of the device history records for the shower bag, lot#: 6975661 showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE GOGEAR WEARABLE ACCESSORIES KIT
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10535401
• Report Number: 2916596-2020-04499
• Device Sequence Number: 11647373
• Product Code: DSQ
• UDI-Device Identifier: 00813024011262
• UDI-Public: 00813024011262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 106129
• Device Catalogue Number: 106129
• Device Lot Number: 6975661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 55