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

Model Number	1318
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the ventricular assist device (vad)'s driveline (dl) cover rubber boot was harden and unable to be retracted and maneuvered.The dl boot cover was wiggled and pulled on for a few minutes and then it was able to retract.The boot cover was cut off and a new rubber boot was placed on with minimal vad time off.The vad's driveline remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for correction.Brand name corrected from heartware ventricular assist system - pump accessory to heartware ventricular assist system - surgical tool.Model # corrected from 1153 to 1318.Catalog # corrected from 1153 to 1318.Expiration date corrected from 09/30/2021 to 01/31/2021.Lot # corrected from t000070 to 1055726.Unique identifier (udi) # corrected from (b)(4) to asku.Device manufacture date corrected from 09/16/2019 to 01/31/2021.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 report is being submitted for device evaluation.Product event summary: the driveline boot cover was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of the driveline cover's inspection documentation revealed that an ncri associated with potential dimensional issues of the device was generated, which may have been related to the reported event.On-site inspection revealed that the driveline cover was stuck on the driveline and could not be removed.Visual inspection of the returned device revealed that the driveline cover was received in a damaged condition; therefore, functional testing and dimensional verification could not be performed.Visual inspection also revealed foreign material within the device, likely due to the handling of the device.Additionally, visual inspection revealed discoloration around the edge of the driveline cover.Supplemental testing previously performed on similar samples revealed that the driveline covers analyzed exhibited increased hardness and material stiffness as compared to a control sample.As a result, the reported event was confirmed.Based on historical review of similar events and the investigation conducted, possible root causes of the reported difficulty removing the driveline cover and hardening of the driveline cover can be attributed, but not limited, to contamination/foreign material between the driveline connector and driveline cover, leaching of the plasticizer from the material, and/or degradation of the material, resulting in hardening.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.
Additional Manufacturer Narrative
A supplemental report is being submitted for inclusion of this event as being in-scope for field action 3007042319-12-06-2022-005-c.This event was submitted historically and has been deemed in-scope for the field corrective action.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 - SURGICAL TOOL
• 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: 11738608
• Report Number: 3007042319-2021-03383
• Device Sequence Number: 17178118
• Product Code: DSQ
• UDI-Device Identifier: 00888707000154
• UDI-Public: 00888707000154
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/20/2022

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 Expiration Date: 01/31/2018
• Device Model Number: 1318
• Device Catalogue Number: 1318
• Device Lot Number: 1055726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 11/12/2021; 12/07/2022
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/01/2021; 11/15/2021; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 300704231912062022005C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 66 YR
• Patient Sex: Male