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

Model Number 104232

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient complained of a hole in their shower bag.The shower bag was not returned to the distributor, and the actual hole was not confirmed.Additional information received on 01oct2020 reported that the patient noticed water inside of their shower bag during their shower.The bag was disposed of.

Manufacturer Narrative

This event occurred at (b)(6) hospital in (b)(6).Section h6: additional information.Section h8: correction.Manufacturer's investigation conclusion: the report of a hole in the patient¿s shower bag could not be confirmed as no product or photos of the damage were received for evaluation.The patient reportedly noticed a hole in their shower bag after noticing water in the bag during a shower on (b)(6) 2020.The gogear shower bag was discarded.No adverse patient consequences were reported in association with the event.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and patient handbook state that the wear and carry accessories should be inspected periodically during use.If there are any issues the item should not be used, and a replacement should be requested.These documents provide instructions for showering with the use of the shower bag.The relevant sections of the device history records for the gogear shower bag were reviewed and 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 SHOWER BAG
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10697776
• MDR Text Key: 211911601
• Report Number: 2916596-2020-04962
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011149
• UDI-Public: 00813024011149
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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
• Device Lot Number: 6855314
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1