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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS INSERTION KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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PERFUSION SYSTEMS BIO-MEDICUS INSERTION KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 96552
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)
Event Date 01/06/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from the customer that a bio-medicus nextgen insertion kit was used as an arterial cannula for an emergency ascending aorta replacement.An issue was noticed after the procedure, that wire remnants at the tip of the cannula spring remained in the patient's blood vessel.The remnants in the blood vessel were confirmed by x-ray and were removed with an additional procedure.There was no adverse effect to the patient.Additional information received from the customer: the guidewire was pulled out with the guidewire clamped through the cannula with tube forceps (although it was unknown how much force it was clamped with).The guidewire broke and it remained inside the blood vessel about 20 to 30cm from the renal artery to the proximal.At the time of removal, even though it was pulled out from around the renal artery and warfarin was taken, it could be confirmed visually that a small amount of thrombus was adhering to the guidewire.It was not considered by the customer to be a product-derived defect.However, the event was submitted to medtronic calling attention to the event due to incorrect usage of the device.
 
Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from the customer that a bio-medicus nextgen insertion kit was used as an arterial cannula for an emergency ascending aorta replacement.An issue was noticed after the procedure, that wire remnants at the tip of the cannula spring remained in the patient's blood vessel.The remnants in the blood vessel were confirmed by x-ray and were removed with an additional procedure.There was no adverse effect to the patient.Additional information received from the customer: the guidewire was pulled out with the guidewire clamped through the cannula with tube forceps (although it was unknown how much force it was clamped with).The guidewire broke and it remained inside the blood vessel about 20 to 30cm from the renal artery to the proximal.At the time of removal, even though it was pulled out from around the renal artery and warfarin was taken, it could be confirmed visually that a small amount of thrombus was adhering to the guidewire.It was not considered by the customer to be a product-derived defect.However, the event was submitted to medtronic calling attention to the event due to incorrect usage of the device.
 
Manufacturer Narrative
Medtronic investigation: analysis found the returned cannula broken in two pieces.After analysis and description provided by the customer, this complaint was determined to a use-related issue.The device history record could not be reviewed as no lot number was provided.A review of complaints received for similar model numbers found no similar occurrences.Assessment against the medtronic risk management file document indicates that the current risk zone does not exceed the risk zone predicted; therefore, no capa will be initiated at this time.There were no adverse patient effects as a result of this incidence.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Medtronic 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.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.
 
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Brand Name
BIO-MEDICUS INSERTION KIT
Type of Device
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
PERFUSION SYSTEMS
7611 northland dr
brooklyn park MN 55428
MDR Report Key11292201
MDR Text Key230670847
Report Number2184009-2021-00006
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
PMA/PMN Number
K190557
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number96552
Device Catalogue Number96552
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Date Manufacturer Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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