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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER; APPARATUS, AUTOTRANSFUSION
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PERFUSION SYSTEMS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER; APPARATUS, AUTOTRANSFUSION Back to Search Results
Model Number 50010
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/01/2019
Event Type  Injury  
Manufacturer Narrative
Medline industries, inc.Forwarded this complaint to medtronic on 17th may 2019.Medline's reference number for reporting is (b)(4): 1423395-2019-00016.Device return has been requested from the customer.Should the device be returned to medtronic, it will be analyzed as part of the ongoing investigation.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of this dlp left atrial pressure monitoring catheter placement set, the tip broke off inside the patient.The tip was subsequently removed.It is unknown how long the catheter placement set was in the patient, how the catheter placement set was being handled at the time of the reported break, or what procedure was required to remove the catheter placement set from the patient.No serious injury, additional medical intervention or follow-up care related to this incident were reported.The customer was unable to provide additional patient, product, or procedural information related to this incident.
 
Manufacturer Narrative
In error, the initial mdr report indicated medline's reference number for reporting as (b)(4): 1423395-2019-00016.The correct mdr report number from medline is (b)(4):1423395-2019-00015.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use the tip of this dlp left atrial pressure monitoring catheter placement set broke off inside the patient.The tip was subsequently removed.See the attached images.It is unknown how long the catheter placement set was in the patient, how the catheter placement set was being handled at the time of the reported break, or what procedure was required to remove the catheter placement set from the patient.No serious injury, additional medical intervention, or follow-up care related to this incident was reported.The customer was unable to provide additional patient, product, or procedural information related to this incident.
 
Manufacturer Narrative
Medtronic investigation: visual inspection shows the tubing is separated from the luer fitting.Complaint is confirmed for tubing being separated from the luer fitting.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.No trends warranting escalation were evident related to this occurrence.The quality online checks that are in place would not allow for this type of defect to pass through our system and may have occurred after it left our facility.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 Description
Medtronic received information that during use the tip of this dlp left atrial pressure monitoring catheter placement set broke off inside the patient.The tip was subsequently removed.See the attached images.It is unknown how long the catheter placement set was in the patient, how the catheter placement set was being handled at the time of the reported break, or what procedure was required to remove the catheter placement set from the patient.No serious injury, additional medical intervention, or follow-up care related to this incident was reported.The customer was unable to provide additional patient, product, or procedural information related to this incident.
 
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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 Key8653226
MDR Text Key146468565
Report Number2184009-2019-00026
Device Sequence Number1
Product Code CAC
Combination Product (y/n)N
PMA/PMN Number
K841482
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model Number50010
Device Catalogue Number50010
Device Lot Number2017070049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2019
Date Manufacturer Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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