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

Model Number CEDTB400L

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2022

Event Type  malfunction  

Event Description

It was reported that during a radiofrequency (rf) ablation procedure, a steam pop was heard. intracardiac echocardiography (ice) was performed and it was unclear if a steam pop occurred. the case was completed with radiofrequency.The date files could not be downloaded due to the generator not recognizing universal serial bus (usb) and external drive. no 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.

• 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: 14059371
• MDR Text Key: 289493728
• Report Number: 3015180993-2022-00010
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CEDTB400L
• Device Catalogue Number: CEDTB400L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/08/2022
• 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 Age: 83 YR
• Patient Sex: Male