MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP PERICARDIAL SUMP; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP

Model Number 12010

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Distress (2329); Unspecified Tissue Injury (4559)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

Section e3 (occupation): this field has been populated as na as this event was reported to medtronic by legal and information on the initial reporter is not available.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.

Event Description

Medtronic received information that during use of a dlp pericardial sump in a routine aortic valve replacement via mini sternotomy, it was reported that the cardiac suction tube and/or sump became entangled in the patient's mitral chords, resulting in conversion of the procedure to a full sternotomy, requiring replacement of mitral valve and re-replacing the aortic valve.Use of the device was unspecified.  the patient was catastrophically injured and suffered from severe pain, distress and injuries including debilitating and incapacitating heart and kidney damage which is permanent in nature.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of the sump getting tangled in the mitral valve chordae resulting in a valve replacement, as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product; however, the entanglement of the sump and subsequent intervention were most likely caused by use error.The instructions for use and the device labeling state "the pericardial sump is not intended to be placed through a valve to drain a closed cardiac chamber." the damage to the valve occurs when the exposed wire coil on the sump tips catches or becomes entangled in the chordae tendinea.During this procedure the pericardial sump was placed into the cardiac chamber contraindicating the warning on the device's labeling and most likely causing the damage to the patient anatomy.The device history record could not be reviewed as no lot number was provided.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.Correction e street 1: this field has been corrected.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

Correction b3 (date of event): this field has been updated.Correction section e (initial reporter): the fields in this section have been updated.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

Note: additional information may be supplied following additional review of the event.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: DLP PERICARDIAL SUMP
• Type of Device: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17001633
• MDR Text Key: 315918234
• Report Number: 2184009-2023-00331
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 12010
• Device Catalogue Number: 12010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/02/2023; 07/06/2023; 09/01/2023
• Supplement Dates FDA Received: 06/13/2023; 08/02/2023; 09/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White