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

Model Number 50010

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Medtronic received information from a medwatch that during use of this cannula bleeding was noted at connection.When it was removed from the patient a crack was noted in the hub.The size of the crack was not reported.It was asked but unknown if the device was replaced.They could not perform appropriate monitoring after surgery.No additional patient effects was reported.No blood loss reported.A blood transfusion was not required.

Manufacturer Narrative

After investigation at medtronic, complaint cannot be confirmed for crack in the luer fitting resulting in blood loss as no product has been returned to date.It is unknown what may have caused this occurrence.A root cause cannot be determined without the returned product.There is the possibility that the cracking of the hub is caused by the use of alcohol based cleaners prior to and during use, however to date, there has been no indication that alcohol was used during this occurrence.The device history record could not be reviewed as no lot number was provided.Complaints received from august 2019 through november 2020 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.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.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.

• 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
• 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: 16919037
• MDR Text Key: 315087380
• Report Number: 2184009-2023-00266
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K841482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50010
• Device Catalogue Number: 50010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 6 MO
• Patient Sex: Female