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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP ACCESSORY; VENTRICULAR (ASSISST) BYPASS
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| Model Number 1175 |
| Device Problem
Difficult to Remove (1528)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 02/28/2022 |
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Event Type
malfunction
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.Concomitant medical products: dvfb1d1 icd implanted: (b)(6) 2017, 693565 lead implanted: (b)(6) 2008.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the ventricular assist device (vad) patient came to the site for a controller exchange and the driveline cover was stuck over the driveline.The healthcare professional attempted to pull off the driveline cover several times without success.Patient successfully pulled the driveline cover and controller exchange was performed without any issues.Driveline cover was placed back on driveline connection.Vad team is deciding whether they would like the driveline cover removed.The driveline cover remainsin use.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information and correction.Additional information was received regarding the reason why the patient went to the clinic.Correction b5: the event description was corrected to include that a controller exchange was not performed.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.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.
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Event Description
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It was further reported that the patient presented to the site for a routine clinic visit and the patient did not receive a controller exchange.
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Manufacturer Narrative
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A supplemental report is being submitted for and update to d4 added the lot number and for investigation completion.Product event summary: the driveline boot cover (lot no.R011226) has not been returned for evaluation.A review of the driveline cover inspection records confirmed that the associated device met all requirements for release.The reported event could not be confirmed due to insufficient information.Based on historical review of similar events, a possible root cause of the reported difficulty removing the driveline cover event 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.
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Event Description
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It was further reported that the driveline cover was removed and replaced.It was noted that the ventricular assist device (vad) was stopped for approximately 15 seconds while the driveline cover was removed.Upon examination of the driveline, the driveline had several breaks in the pellethane with rescue tape that had been placed by hospital staff.Residue was also seen and cleaned from the driveline, and the driveline had a dark brown discoloration.The rescue tape was removed and the wires appeared in tact.Servicing was performed on the driveline and the driveline remains in use.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information.B5 was updated with additional information; h10 updated to include the pump/driveline as a system reported device.Additional products: d1: heartware ventricular assist system ¿ pump/driveline d4: model #: 1103 / catalog #: 1103 / expiration date: 31-mar-2015 / serial or lot#: (b)(6), udi #: (b)(4), d9: no, yes, return date: dd-mmm-yyyy: h3: no, device evaluation anticipated, but not yet begun h4: mfg date: 31-mar-2013, h5: yes, h6: patient ime code(s): e0403 h6: imf code(s): f26 h6: img code(s): g02004, g04105 h6: fda device code(s): a04, a180104, a141204 h6: fda method code(s): b21 h6: fda results code(s): c21 h6: fda conclusion code(s): d16 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.
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Manufacturer Narrative
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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.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.
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Manufacturer Narrative
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###a supplemental is being submitted for additional information.Additional products: (b)(6) ¿ pump/driveline h6: img code(s): g04034 h6: fda method code(s): b14, b17, b15 h6: fda results code(s): c07, c15 h6: fda conclusion code(s): d01, d06, d11 product event summary: the driveline boot cover (lot r011226) was returned for evaluation.The driveline cable associated with (b)(6) was not returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the devices in relation to the reported event.A review of the driveline cover's inspection documentation and the pump's manufacturing documentation confirmed that the associated devices met all requirements for release.Review of the available logfiles did not reveal any anomalies related to the reported event within the analyzed period.On-site inspection of the driveline cover revealed that the device was stuck and could not be moved.Visual inspection of the returned driveline boot cover 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 driveline cover and discoloration around the edges 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.On-site inspection of the driveline cable revealed new damage to the outer sheath near a previous repair and discoloration of the outer sheath.On-site inspection also revealed contamination, likely from an external source, between the driveline cover and outer sheath.A driveline sheath repair was performed to mitigate the reported driveline damage.No vad stopped alarms were logged within the analyzed period; however, the pump was stopped during the driveline sheath repair procedure to replace the controller and driveline boot cover.As a result, the reported events were confirmed.Based on historical review of similar events and the investigation conducted, a possible root cause of the reported difficulty removing the driveline cover event can be attributed, but not limited, to contamination/foreign material between the driveline sheath and driveline cover, leaching of the plasticizer from the material and/or degradation of the material, resulting in hardening.Capa pr00536773 is further investigating this issue.Hardening.A possible root cause of the reported foreign material between the driveline sheath and driveline cover be attributed, but not limited to the handling of the device.Based on historical review of similar events, the most likely root cause of the driveline sheath dam age and discoloration may be attributed to multiple factors including design issues and/or exposure to uv light.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.
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