MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number PN-004 075

Device Problems Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 01/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

At the end of an atrial fibrillation ablation procedure, the patient became hypotensive and experienced chest pain.An echocardiogram revealed a pericardial effusion on the left side of the heart.A pericardiocentesis was performed to stabilize the patient.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.In addition, no log files were provided for evaluation.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk with the use of this device.

Manufacturer Narrative

The results of the investigation concluded that the catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to the bends in the shaft.In addition, the device met specifications for electrical testing, temperature testing, and optical signal properties.Contact force was displayed when connected to the tactisys unit, with no error messages noted.The device met specifications prior to release from abbott manufacturing facilities as supported by the device history record.The cause of the bends in the shaft is consistent with damage during use.The cause of the reported cardiac perforation remains unknown.Per the ifu, cardiac perforation is a known risk with the use of this device.

• Brand Name: TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER, 75MM
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6298282
• MDR Text Key: 66433297
• Report Number: 0009680001-2017-00009
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130026
• 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,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2018
• Device Model Number: PN-004 075
• Device Lot Number: 5420424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 SE CATHETER; AGILIS STEERABLE INTRODUCER
• Patient Outcome(s): Required Intervention