MAUDE Adverse Event Report: EPIX THERAPEUTICS DIAMONDTEMP; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number CEDT200L

Device Problem No Apparent Adverse Event (3189)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a radiofrequency procedure, one incident of steam pop occurred.The case was completed with radiofrequency.The patient is a participant in a clinical study.No patient complications have been reported as a result of this event.

• Brand Name: DIAMONDTEMP
• Type of Device: PERCUTANEOUS CATHETER INTENDED 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11709026
• MDR Text Key: 249323555
• Report Number: 3015180993-2021-00008
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P200028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Model Number: CEDT200L
• Device Catalogue Number: CEDT200L
• Device Lot Number: 0000218564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2021
• Date Device Manufactured: 11/24/2020
• 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: 77 YR
• Patient Weight: 62