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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA INTRODUCER, CATHETER

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MEDTRONIC, INC. MICRA INTRODUCER, CATHETER Back to Search Results
Model Number MI2355A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Thrombus (2101); Cardiac Tamponade (2226); Aortic Dissection (2491); Pseudoaneurysm (2605); Pericardial Effusion (3271)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The baseline gender/age characteristics is male/77 years old. Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿acute and long-term outcomes of simultaneous atrioventricular node ablation and leadless pacemaker implantation. ¿ pacing clin electrophysiol. 2018; 41: 1484¿1490. Doi: 10. 1111/pace. 13496. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reported the following patient complications during the introducer sheath used for femoral access for the implantation of a leadless pacemaker and/or the use of a radio frequency ablation catheter: there was one (1) patient who experienced cardiac tamponade which required pericardial drainage. There was also one (1) patient with a ¿moderate¿ pericardial effusion, which resolved with conservative management and did not add any extra hospitalization. In one (1) patient the ¿left femoral vein was used to implant the device because the right femoral vein showed excessive tortuosity and a local dissection. The patient was discharged 24 hours after the procedure, with no short- or long-term complications within the follow-up period. ¿ there were three (3) patients with an arteriovenous fistula; with no treatment/resolution indicated. There were also two (2) patients with arteriovenous pseudoaneurysms; with no indication of treatment/resolution. There was one (1) patient with a venous thrombosis, with no indication of treatment/resolution. Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method. The status/location of the sheath is unknown. Further follow up did not yet yield any additional information. No further patient complications have been reported as a result of this event.
 
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Brand NameMICRA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8275961
MDR Text Key134036834
Report Number2182208-2019-00163
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K132030
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMI2355A
Device Catalogue NumberMI2355A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2019 Patient Sequence Number: 1
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