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

Model Number CEDTB400L

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

Patient Problems Anemia (1706); Fatigue (1849); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 11/03/2022

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 during a radiofrequency (rf) ablation procedure, bleeding occurred at the femoral puncture site requiring no particular action.The case was completed with radiofrequency.Post-operatively, the patient was anemic and symptomatically hypotensive.Intravenous fluids were given.An infracentimetric hematoma at the scarpa triangle was observed on a doppler.There was no active bleeding from the hematoma at the puncture site.An ultrasound was performed and confirmed there was no pericardial effusion.The patient was discharged the following day.Five days later, the patient returned with a sudden onset of pain.A large, bulging hematoma opposite of the right inguinal puncture site was observed.The patient's pain was treated with analgesics.A blood test showed no deglobulation.An abdominal and pelvic scan revealed hematoma of the right pectineal muscle with minimal active arterial bleeding.The patient returned home the same day with instructions to ice the affected area.Four days later, an external echo-doppler was performed and the patient was hospitalized due to increased pain "disabling walking," decreased appetite, and fatigue.A compression test under ultrasound guidance showed volumetric increase of the hematoma in the right pectineal muscle and the underlying active art erial bleeding.Two days into the patient's hospitalization, a computerized tomography (ct) scan showed volumetric stability of the hematoma without signs of residual active bleeding.The patient was discharged the following day.The patient is a participant in a clinical study. no further patient complications have been reported as a result of this event.

• 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: 15979578
• MDR Text Key: 305466053
• Report Number: 3015180993-2022-00040
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P200028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2023
• Device Model Number: CEDTB400L
• Device Catalogue Number: CEDTB400L
• Device Lot Number: 0000226198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Date Device Manufactured: 05/10/2022
• 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