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

Model Number CEDT100S

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bronchitis (1752)

Event Date 05/05/2021

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 (rf) ablation procedure, a steam pop occurred.It was also noted that post procedure, the patient had acute bronchitis.Medication was administered and the patient required extended hospitalization.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.

Manufacturer Narrative

Product event summary: the data files and cedt100s radiofrequency catheter with lot 210505080050 were returned and analyzed.The data files showed impedance values were high at the end of ablations.Visual inspection of the distal shaft of the catheter was observed to be bent.The reported steam pop issue could not be replicated under the testing environment.However, the radiofrequency catheter passed electrical test and isolation test.In conclusion, the reported steam pop could not be confirmed through testing.The radiofrequency catheter passed the returned product inspection as per specification.Correction: b3 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.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
• MDR Report Key: 11848150
• MDR Text Key: 252090676
• Report Number: 3015180993-2021-00010
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P200028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: CEDT100S
• Device Catalogue Number: CEDT100S
• Device Lot Number: 0000217064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Weight: 106