MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER; APPARATUS, AUTOTRANSFUSION

Model Number 50010

Device Problems Material Puncture/Hole (1504); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection shows the device is in 2 sections and the luer fitting is damaged/cracked.Reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a 50010 dlp left atrial pressure monitoring catheter placement set, the customer observed that the line was not flowing so they clamped the line.While inspecting the line they noticed where they had clamped that a piece had broken and also noticed that the luer had a crack in it.Before making the connection the nursing staff used alcohol to wipe.The device was replaced.There was no patient impact associated with this event.

Manufacturer Narrative

Additional information received - the customer stated that there was no concern regarding a piece of the device falling into the patient.The customer stated that they did not specifically inspected for any defect.The customer stated that there was no note of any defect ¿felt¿ with the alcohol scrub.The device was inspected when the event occurred, and the crack in the hub and piece of plastic in the stopcock leur was then noted.No issues with line were noted during use of the device prior to this event occurring.The device had been in use for 4 days when this event occurred.The event occurred with a tubing change with this device, as per policy.The customer stated that they think the alcohol scrub somehow affected the hub of the device and when the stopcock was connected, the hub cracked.Information about avoiding alcohol was in the package insert, which, was tossed out in the operating room and not available to the icu staff.The customer stated that the challenge with this device is that there is no ¿clamp¿ on the line for tubing changes or otherwise accessing the line.The customer's solution now is to place a stopcock on the line in the or and consider it as one sterile unit with no need to change the stopcock with infusion line changes.After investigation at medtronic, complaint is confirmed for damage to the luer fitting.It is unknown what may have caused this occurrence - however, there is the possibility that the cracking of the hub is caused by the use of alcohol based cleaners prior to and during use and the clamping by the user.The instructions for use (ifu) contains a warning cautioning users that the luer hub should not come into contact with alcohol-based solutions.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from june 2020 through july 2021 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.If the product is returned, this pe will be reopened and the analysis and investigation will be updated.There were no adverse patient effects as a result of this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends per the product quality meetings procedure.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.

• Brand Name: DLP LEFT ATRIAL PRESSURE MONITORING CATHETER
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 12065562
• MDR Text Key: 258383813
• Report Number: 2184009-2021-00051
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K841482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: 50010
• Device Catalogue Number: 50010
• Device Lot Number: 2020070803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1