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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
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MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT Back to Search Results
Model Number 990063-020
Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 02/01/2024
Event Type  Injury  
Manufacturer Narrative
Select patient information cannot be provided due to regional privacy regulations.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
It was reported that during a cryo ablation procedure, the mapping catheter could not be retracted into the balloon catheter.Both products were protruding from the sheath upon removal from the patient.A tissue fragment, surmised to be a part of the endocardium, was attached to the mapping catheter upon removal.The mapping catheter was subsequently replaced.The case was completed with cryo.A computerized tomography (ct) scan was performed the following day and no abnormalities were observed.No further patient complications have been reported as a result of this event.
 
Event Description
It was reported that during a cryo ablation procedure, the mapping catheter could not be retracted into the balloon catheter.Both products were protruding from the sheath upon removal from the patient.A tissue fragment, surmised to be a part of the endocardium, was attached to the mapping catheter upon removal.The mapping catheter was subsequently replaced.The case was completed with cryo.A computerized tomography (ct) scan was performed the following day and no abnormalities were observed.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the 990063-020 mapping catheter with lot number 227846028 was returned and analyzed.Visual inspection of the loop segment area showed: the loop was kinked and ribbed near electrode #8.The user may experience insertion difficulties due to this issue when introducing the mapping catheter into the balloon catheter.No missing electrodes were observed.Visual inspection of the pebax segment was performed.Tissue adhered to the tip of the mapping catheter was observed.Visual inspection of the shaft segment area showed: the shaft was broken approximately 59 inches from the lemo connector, inspection also identified broken wires at the broken shaft area.In conclusion, the reported tissue adherence and compatibility issue were confirmed during analysis and the mapping catheter failed the returned product inspection due to human tissue was observed on the mapping catheter.A kink was observed at the tip/loop of the pebax tubing.A broken shaft was observed.An electrode wire was broken in the shaft segment.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
ACHIEVE MAPPING CATHETER - 20 MM
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX  22210
Manufacturer (Section G)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX   22210
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key18720473
MDR Text Key335573580
Report Number9617601-2024-00022
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K102588
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number990063-020
Device Catalogue Number990063-020
Device Lot Number227846028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/01/2024
Initial Date FDA Received02/16/2024
Supplement Dates Manufacturer Received02/26/2024
Supplement Dates FDA Received03/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/29/2023
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) Other;
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