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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRA; INTRODUCER, CATHETER
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MICRA; INTRODUCER, CATHETER Back to Search Results
Model Number MI2355A
Device Problem Use of Device Problem (1670)
Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208); Loss of consciousness (2418)
Event Date 07/15/2021
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient is deceased.During the implant of the leadless implantable pulse generator (ipg) deployment was performed four times.The leadless ipg catheter was taken out of the body and a flush was attempted before the fifth deployment.It was also reported that introducer sheath had moved around to the puncture site and subsequently the introducer sheath was inserted into the incorrect vessel against resistance causing a puncture in the inferior vena cava.During fifth deployment after the tether cutting, it was observed that the arterial pressure had dropped.Since the venous dissociation was concerned when the introducer sheath was inserted, contrast enhanced computerized tomography (ct) from the inferior vena cava was performed that showed an abnormality in the vein, the sediment formed around the iliac vein.While noradrenaline was rapidly administered, the tether cut was completed once.It was decided that a laparotomy was required as well for the patient to arrest hemorrhage at the site.When the abdomen was opened to the upper part, ruptures were found at site near the inferior vena cava that arrest of hemorrhage required for a long time since the blood vessels were tattered.Although the setting of the leadless ipg was set to high output, loss of consciousness was observed, and cardiac arrest completely occurred and the patient died.
 
Manufacturer Narrative
Product event summary: a partial introducer was returned, analyzed, and no anomalies were found.The delivery system introducer sheath was kinked/buckled.The sheath of the delivery system introducer was damaged.Visual analysis of the introducer indicated damage during use.The analyst noted only two segments of the sheath of the introducer were returned.The distal edge of the sheath of the introducer was damaged.The sheath of the introducer was kink buckled at 16.3 cm, 19.9 cm, 28.5 cm, and 35.8 cm from the distal end of the sheath of the introducer.The sheath of the introducer was cut at 31 cm and 38.2 cm from the distal end of the sheath of the introducer.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.
 
Manufacturer Narrative
Correction: h6.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
MICRA
Type of Device
INTRODUCER, CATHETER
MDR Report Key12273902
MDR Text Key264946324
Report Number9612164-2021-02999
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/12/2023
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Device Lot Number00155778
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2021
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age87 YR
Patient Weight50
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