MAUDE Adverse Event Report: EPIX THERAPEUTICS DIAMONDTEMP¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number CEDT100S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Chest Pain (1776); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 04/03/2023

Event Type  Injury  

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.

Event Description

It was reported that following a radiofrequency (rf) ablation procedure, there was bleeding at the access site in the right groin.A femoral compression system was used to stop the bleeding.Manually pressure was performed for ten minutes and a pressure bandage was applied.The groin was very painful and pain medication was administered. the patient's hemoglobin was low.No treatment was given for the anemia.The patient complained of chest pain, pain between shoulder blades and a heavy feeling in the left arm.An electrocardiogram (ecg)was performed and the results were abnormal.A nitrate vasodilator and a depressant medication were administered once.Additionally, the patient was started on a pain medication.Another electrocardiogram (ecg) was performed the next day and the results were normal.The case was completed with radiofrequency.The patient is a participant in a clinical study. no further patient complications have been reported as a result of this event.

Event Description

2023-09-01, additional information was received reporting approximately three and a half months after the ablation procedure, the patient had a follow-up visit with the cardiologist.The cardiologist thought the patient looked pale.The patient¿s hemoglobin was abnormal.It was noted that the patient had iron tablets prescribed by the general practitioner.The patient was advised to follow-up with general practitioner.The general practitioner switched the patient to a new iron tablet.

Manufacturer Narrative

B5: updated event description.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.

• Brand Name: DIAMONDTEMP¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): EPIX THERAPEUTICS; 945 stewart drive; suite 100; sunnyvale CA 94085
• Manufacturer (Section G): EPIX THERAPEUTICS; 945 stewart drive; suite 100; sunnyvale CA 94085
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16743050
• MDR Text Key: 313321319
• Report Number: 3015180993-2023-00007
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P200028
• Number of Events Reported: 1
• 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: 09/01/2023

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 Expiration Date: 02/14/2023
• Device Model Number: CEDT100S
• Device Catalogue Number: CEDT100S
• Device Lot Number: 0000225746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 09/01/2023
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention