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

Model Number	12116
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the complaint device was not returned.Visual inspection of the (b)(4) unopened devices shows no evidence of the wire protruding through the cannula tip.(b)(4) devices will be sent back to the supplier for additional analysis.The photo of the complaint device shows evidence of the wire protruding through the tip.Reason for return was visually confirmed by the photo provided by the customer.Conclusion: after investigation at medtronic, complaint is unconfirmed for wire protruding from the left heart vent catheter.There was no observed damage to the returned devices and performance testing indicated that the device functions as intended.All devices returned were unopened and the complaint device was not returned.It is unknown what may have caused this occurrence.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 per the product quality meetings procedure.1) pouched product from both lots were returned and did not observe any outwards signs of damage to either the pouches or product.2) pouches were then opened for each lot for additional inspection.See photos.The (b)(4) returned pouches for complaint lot 2020020093 was visually inspected and did not observe any wire protruding from the tip.The five returned pouches for complaint lot 2019081291 was visually inspected and did not observe any wire protruding from the tip.3) review of ml-qp-010109 step 2.5 is the forming of the tip on the tubing.Each tubing assembly is visually inspected after the forming has been completed for the seal of the small lumen, the tip holes are opened completely, no flash on the tip or any oil residue on the tip.If any of these defects are found, the assembly is to be rejected.Step 2.7 is the insertion of the wire into the small lumen.After insertion each device is visually inspected to ensure the wire is not protruding.If you see or feel the wire with your finger the tubing is to be rejected.4) complaint cannot be confirmed at this time.All returned product from the field both lots could not verify the defect as described in the complaint.Actual product was not returned and cannot determine the cause of the defect.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa 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.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 of a 12116 dlp left heart vent catheter, it was noted that the wire of the cannula was protruding through the cannula tip.The cannula was replaced to complete the procedure.The customer stated that all of the other cannulae in the pack had the same issue.There were no adverse patient effects as a result of this issue.Additional information received: the customer has indicated that another cannula lot also has this issue.The issue with both lots were noted at the same time.All of the cannula for each effected lot had the same issue.All cannulae will be returned for analysis.The cannula from lot 2019081291 was used during a procedure, but was replaced to complete the procedure.There were no adverse patient effects.The below quantities of each lot will be returned for analysis: (b)(4), one pack of 2019081291 (b)(4), one pack of 2020020093 (b)(4) of 2019081291 (b)(4) of 2020020093.
Additional Manufacturer Narrative
Correction h6: fdm/annex b and fdr/annex c 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.

• 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
• 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: 17323886
• Report Number: 2184009-2023-00826
• Device Sequence Number: 15032570
• Product Code: DTS
• UDI-Device Identifier: 00643169086715
• UDI-Public: 00643169086715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2023

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: 08/31/2022
• Device Model Number: 12116
• Device Catalogue Number: 12116
• Device Lot Number: 2019081291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown