Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS Back to Search Results
Model Number C315S1002
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)
Event Date 12/23/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the of the implantable pacing lead (ipl) on the right side, insertion of the lead became difficult because due to the delivery catheter was kinked, and a site with favorable threshold could not be found in the area that was reached with the delivery catheter.It was also reported that the patient's blood pressure gradually decreased during manipulation of the delivery catheter.Therefore, the ipl was removed and replaced with a right atrial (ra) lead.The ra lead was successfully placed at a site where favorable data was measured.However, the patient's blood pressure decreased, and an echocardiography was placed over the chest and confirmed cardiac tamponade due to perforation.A drainage procedure was performed, the patient's blood pressure recovered and the procedure was continued.The ra lead was implanted, and the procedure was successfully completed.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product event summary the delivery catheter was returned and analyzed.The analysis indicated that the mechanical operation of the catheter shaft was kinked/buckled.The mechanical operation of the catheter was analyzed.The mechanical operation of the catheter was damaged.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned without the dilator.There is blood in the hemostasis valve.The shaft is twisted at 18.5 centimeters.The shaft is kinked at 41.7 centimeters.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during the of the implantable pacing lead (ipl) on the right side, insertion of the lead became difficult because due to the delivery catheter was kinked, and a site with favorable threshold could not be found in the area that was reached with the delivery catheter.It was also reported that the patient's blood pressure gradually decreased during manipulation of the delivery catheter.Therefore, the ipl was removed and replaced with a right atrial (ra) lead.The ra lead was successfully placed at a site where favorable data was measured.However, the patient's blood pressure decreased, and an echocardiography was placed over the chest and confirmed cardiac tamponade due to perforation.A drainage procedure was performed, the patient's blood pressure recovered and the procedure was continued.The ra lead was implanted, and the procedure was successfully completed.No further patient complications have been reported as a result of this event.
 
Event Description
It was reported that during the implantable pacing lead (ipl) implant on the right side, insertion of the lead became difficult because due to the delivery catheter was kinked, and a site with favorable threshold could not be found in the area that was reached with the delivery catheter.It was also reported that the patient's blood pressure gradually decreased during manipulation of the delivery catheter.Therefore, the ipl was removed and replaced with a right atrial (ra) lead.The ra lead was successfully placed at a site where favorable data was measured.However, the patient's blood pressure decreased, and an echocardiography was placed over the chest and confirmed cardiac tamponade due to perforation.A drainage procedure was performed, the patient's blood pressure recovered and the procedure was continued.The ra lead was implanted, and the procedure was successfully completed.No further patient complications have been reported as a result of this event.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEFLECT
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key9593713
MDR Text Key175187005
Report Number9612164-2020-00251
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K101885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberC315S1002
Device Catalogue NumberC315S1002
Device Lot Number0009653909
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/24/2019
Date Manufacturer Received02/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age84 YR
-
-