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

Model Number	12116
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that following use upon removal of the dlp left heart vent catheter, the customer reported the introducer was extruding from the tip of the device.The device had been used to complete the case.There was no patient impact or effect on the course of the procedure.Nothing unusual was noted during device inspection prior to use.The device was not manipulated excessively in any way.
Event or Problem Description
Medtronic received information that following use upon removal of this dlp left heart vent catheter, the customer reported the introducer was extruding from the tip of the device.See attached image.The device had been used to complete the case.There was no patient impact or affect on the course of the procedure.Additional information from the customer confirmed this is the second event of this type with this batch.The customer stated that they do not have any more information on the other occurrence.Nothing unusual was noted during device inspection prior to use.The device was not manipulated excessively in any way.One of the complaint cannulae is not recoverable and has been destroyed, the other is intended to be returned to medtronic.
Additional Manufacturer Narrative
B5.Desc evt problem additional information provided.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
Conclusion: the complaint is confirmed for the malleable wire coming out of the cannula tip.No product has been returned to date.A root cause of this occurrence cannot be determined without returned product.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.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.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 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.

• 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: 11783667
• Report Number: 2184009-2021-00036
• Device Sequence Number: 1321058
• 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 Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2021

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: 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?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 06/16/2021; 06/16/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 05/19/2021; 07/01/2021; 10/12/2021
• 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
• Patient Age: 68 YR
• Patient Weight: 74