MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOWER BAG; VENTRICULAR (ASSISST) BYPASS

Model Number	2000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shower bag was worn and had some leaking.The shower bag was replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Concomitant medical products: dvab1d4 icd and 6935m62 lead, implanted (b)(6) 2017.Investigation of this event is pending and a supplemental report will be sent upon its completion.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A supplemental is being submitted for additional information.Product event summary: the shower bag (lot no.1264463) was returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the pack in relation to the reported event.Visual inspection during failure analysis of the shower bag revealed that the stitching and the bag itself did not exhibit signs of damage or evidence/traces of fluid that could contribute to the reported event.To address the allegation of shower bag leakage, the design documentation was reviewed.The outer shower bag has a hole for drainage to prevent the bag from filling with water.In addition, this component includes an inner shower bag to protect the controller and batteries from any water ingress from the outer bag.It is likely that the customer perceived water drainage from the outer bag as the reported ¿leakage¿; however, the outer shower bag is designed to drain fluid during shower conditions, thus preventing the bag from filling with water and fluid ingress to the inner shower bag.Based on the information available, the reported event could not be c onfirmed since no traces of fluid were observed.Considering that there is no evidence of a device malfunction or deviations from current device specifications, the most probable root cause of the reported event can be attributed to a customer perception issue.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOWER BAG
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15573987
• Report Number: 3007042319-2022-07936
• Device Sequence Number: 6158880
• Product Code: DSQ
• UDI-Device Identifier: 00888707000031
• UDI-Public: 00888707000031
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 1264463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD.
• Patient Age: 61 YR
• Patient Sex: Female