MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number G407211

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

Patient Problem Cardiac Perforation (2513)

Event Date 11/07/2017

Event Type  Injury  

Event Description

Related manufacturer reference number: 3005334138-2017-00230, 3005334138-2017-00231, 3005334138-2017-00232, 3005334138-2017-00234.During a persistent atrial fibrillation ablation procedure a pericardial effusion occurred.The patient was not under general anesthesia and a double transseptal access was obtained.After transseptal access was completed a map of the left atrium was performed followed by a box isolation (pulmonary vein isolation, a roof line and a posterior/inferior line) and left isthmus ablation.The power was at 25 watts with irrigation set at 17 cc during the posterior wall ablation and 35 watts with 30 cc irrigation during the remaining ablation.The impedance cut off was programmed on the generator (variation of 20 ohms during 3 seconds) and the progressive rise of power was programmed on 6 seconds.Approximately 5300 seconds of ablation was performed during the procedure and at times the power was difficult to reach due to the temperature limit that was set on the generator (40 degrees, 20 watts).The patient¿s blood pressure remained stable during all the ablations but the heart contraction seemed not as strong so an echocardiogram was performed which showed some blood on the right side of the heart, anteriorly from the right ventricle.A pericardiocentesis was performed and the heart contraction returned to normal.It was decided to continue with the procedure and ablation of the cavotricuspid isthmus.During the right isthmus ablation in trabeculated tissue an audible pop was heard so ablation was ceased and the catheter removed.Upon flushing this ablation catheter it was observed that two of the holes were not flushing as intended.Another catheter was used to complete the procedure and there were no further issues.The patient remained in stable condition.

Manufacturer Narrative

A pericardial effusion was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: BRK¿ XS TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7058927
• MDR Text Key: 92921587
• Report Number: 3008452825-2017-00305
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072278
• 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,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: G407211
• Device Lot Number: 6105905
• Other Device ID Number: 05414734205153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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
• Treatment: ADVISOR CATHETER.; AGILIS INTRODUCER,; SWARTZ INTRODUCER,; TACTICATH CATHETER,
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR