MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP

Model Number	12116
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use, the customer reported on (b)(6) 2021 in the vascular surgery block, the care team encountered a problem when the left heart vent cannula was removed.They had a lot of trouble putting the cannula in, and on removal they found that the rigid metal band had come out of its plastic sheath and was most likely the cause of a wound to the patient's left atrium.The device was used to complete the case.Patient status status following the case was described as: alive - no injury.
Additional Manufacturer Narrative
Initial analysis: visual inspection showed the wire protruding through the tip of the cannula.Device evaluation is ongoing and medtronic's completed investigation will be provided in a subsequent supplemental 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.
Event or Problem Description
Medtronic received information that during use, the customer reported on (b)(6) 2021 in the vascular surgery block, the care team encountered a problem when the left heart vent cannula was removed.They had a lot of trouble putting the cannula in, and on removal they found that the rigid metal band had come out of its plastic sheath and was most likely the cause of a wound to the patient's left atrium.The device was used to complete the case.Patient status following the case was described as: alive - no injury.Additional information received - the surgeon had to make a suture on the left atrium to stop the bleeding.It was confirmed that nothing came off the cannula.
Additional 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.
Additional Manufacturer Narrative
Medtronic investigation: after investigation at medtronic, complaint 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, this investigation will be reopened 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.
Event or Problem Description
Medtronic received information that during use, the customer reported on 2nd january 2021 in the vascular surgery block, the care team encountered a problem when the left heart vent cannula was removed.They had a lot of trouble putting the cannula in, and on removal they found that the rigid metal band had come out of its plastic sheath and was most likely the cause of a wound to the patient's left atrium.The device was used to complete the case.Patient status following the case was described as: alive - no injury.Additional information received - the surgeon had to make a suture on the left atrium to stop the bleeding.It was confirmed that nothing came off the cannula.

• Brand Name: DLP LEFT HEART VENT CATHETER
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 11342017
• Report Number: 2184009-2021-00007
• Device Sequence Number: 3737373
• Product Code: DTS
• UDI-Device Identifier: 00643169086715
• UDI-Public: 00643169086715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K834352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 12116
• Device Catalogue Number: 12116
• Device Lot Number: 2020050352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/02/2021; 03/30/2021; 03/30/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/30/2021; 04/08/2021; 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2504-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other