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

Model Number 104232

Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

Related manufacturer report number: 2916596-2022-01861.It was reported that the patient was on a cruise and their system controller got extremely wet.The system controller was in a shower bag at the time of the event.Water had pooled into the pocket of the bag where the controller was, which had caused water damage to the device.Both batteries were fully charged, but the controller only received power from one battery.Within 15-20 minutes of the water damage, the battery stopped reading power form wither battery.The patient had to use their mobile power unit (mpu) until they made it back to the country and was admitted to a hospital in the united states on (b)(6) 2022.Upon this admission the patient had their system controller exchanged.The patient's log files contained a few no external power events on (b)(6) 2022 and (b)(6) 2022.These events were brief and there was no interruption in pump support.There were also a few low flow events that occurred on (b)(6) 2022.The low flow alarms were a result of the patient having been hypertensive and hypovolemic due to their traveling.

Manufacturer Narrative

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 patient was on a cruise.During a day excursion, the patient was involved in several outdoor activities that caused their heartmate gogear shower bag to become damaged and then retain water.The patient felt that the shower bag was the safer option for them to use that day since there was the chance they might get wet.Per the account, this was absolutely not what they recommended.Once the shower bag was unknowingly damaged and then water was introduced, it pooled in the pocket where the controller is stored.The center believes this is how the controller became damaged since there weren t large amounts of water reported in the bag (refer to mfr# 2916596-2022-01861 for the controller evaluation).The patient did not have their backup controller with them and was transferred via ambulance to a ¿hospital¿ in honduras before being life flighted to the united states for treatment.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and no further events have been reported at this time.The heartmate gogear shower bag was discarded prior to the life flight and will not be returned for evaluation.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 lvas instructions for use (ifu) and heartmate 3 lvas patient handbook state 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.

Event Description

It was reported that the heartmate gogear shower bag had a hole in it that was caused by inappropriate use during outdoor activities.This was reportedly what lead to the fluid ingress and subsequent controller exchange.The account noted that the use of the shower bag during outdoor activities was not recommended, but the patient had felt that the shower bag was the safer option for them to use that day since there was the chance they might get wet.The account reported that there was no unexpected malfunction of the heartmate gogear shower bag, the damage was due to operator error.

• Brand Name: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14024974
• MDR Text Key: 288711682
• Report Number: 2916596-2022-10233
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: 00813024011149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• 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
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American