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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
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PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP Back to Search Results
Model Number 12116
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Laceration(s) (1946)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use, the customer reported the wire of the pediatric nextgen cannula extruded and made a small hole into the patient's ventricle.The hole was closed with a patch.Patient survived with no further complications.
 
Event Description
Medtronic received information that during use, the customer reported the wire of the dlp left heart vent catheter extruded and made a small hole into the patient's ventricle.See attached image of device.The hole was closed with a patch.Patient survived with no further complications.Additional information: the physician could not specify exactly at what point in the procedure the device issue occurred, but it was during the procedure.The device was not inspected prior to procedure - only afterwards.However, after the procedure the physician inspected all devices of the same lot number and stated that they all look kind of thin around the metal tip area.They stated the device was not manipulated or handled in any way that could have caused the wire extrusion.
 
Manufacturer Narrative
Medwatch - form fda 3500a; a.Patient information: information provided.B5.Desc evt problem: updated information provided.Initial analysis of the returned complaint device indicates a wire protruding from the tip of the device.The investigation of the returned device is ongoing.Medtronic will provide an updated assessment and conclusion in a subsequent sup plemental mdr.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.
 
Manufacturer Narrative
B5.Desc evt problem corrected device name to: dlp left heart vent catheter.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.
 
Event Description
Medtronic received information that during use, the customer reported the wire of the dlp left heart vent catheter extruded and made a small hole into the patient's ventricle.See attached image of device.The hole was closed with a patch.Patient survived with no further complications.
 
Event Description
Medtronic received information that during use, the customer reported the wire of the dlp left heart vent catheter extruded and made a small hole in the patient's ventricle.The hole was closed with a patch.Patient survived with no further complications.The physician could not specify exactly at what point in the procedure the device issue occurred, but it was during the procedure.The device was not inspected prior to procedure - only afterwards.After the procedure the physician inspected all vents of the same lot number and thought that they all look kind of thin around the metal tip area.The customer stated the device was not manipulated or handled in any way that may have caused the wire extrusion.
 
Manufacturer Narrative
Medtronic investigation: after investigation of the returned device, the issue is confirmed for the malleable wire coming out of the cannula tip.It is unknown what may have caused this occurrence.However, there is a possibility that the wire came out of the cannula tip after excessive manipulation of the malleable wire.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.This investigation was completed with the information that was provided.If additional information is received, the complaint will be reopened and updated if deemed necessary.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends.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.
 
Manufacturer Narrative
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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Brand Name
DLP LEFT HEART VENT CATHETER
Type of Device
SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
MDR Report Key11663451
MDR Text Key245328579
Report Number2184009-2021-00020
Device Sequence Number1
Product Code DRA
UDI-Device Identifier00643169086715
UDI-Public00643169086715
Combination Product (y/n)N
PMA/PMN Number
K834352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model Number12116
Device Catalogue Number12116
Device Lot Number2020050699
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2021
Date Manufacturer Received09/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2504-2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight79
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