MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS NXT INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

Related manufacturing reference: 3008452825-2024-00026, 3005334138-2024-00018, 3005334138-2024-00019.The following was published in anatolian journal of cardiology.2023;27(12):697-705."pre-procedural right atrial diameter may predict the development of typical atrial flutter in patients undergoing catheter ablation for atrial fibrillation"; ulus t, al a, durmaz fe, karakus e, çolak e.One hundred fifty-nine patients who underwent catheter ablation for the first time due to atrial fibrillation and who did not have a previously documented atrial flutter were included in the study.Before ablation, baseline clinical features and echocardiographic parameters were recorded.At the 1st, 3rd, 6th, and 12th months after the procedure, and then annually, the patients were followed up for typical atrial flutter development.At a mean follow-up of 34.0 months, typical atrial flutter developed in 21 patients.During the follow-up, right atrial diameter was greater in those who developed typical atrial flutter than those who did not.A multiple cox regression analysis showed that the right atrial diameter was the only independent predictor of typical atrial flutter development.A receiver operating characteristic analysis showed that the best cutoff for the right atrial diameter was 38.5 mm to predict typical atrial flutter development.1 arterioventricular fistula requiring surgical repair was reported.  patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

Manufacturer Narrative

Concomitant devices: tacticath¿ contact force ablation catheter, sensor enabled¿, swartz¿ introducer sl0, swartz¿ introducer sl1.

Event Description

Follow up report needed to address analysis and updated codes.Additional information received from the reporting person confirmed that the physician does not allege any abbott device caused or contributed to the reported arteriovenous fistula or groin complications.Additionally, there was no intervention needed to treat the reported groin complications, making this event not reportable.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AGILIS NXT INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18531220
• MDR Text Key: 333087056
• Report Number: 3008452825-2024-00040
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening