MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number A701125

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.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 sjm specifications and procedures.Based on the information received, the cause of the reported cardiac perforation may have been procedure related.Per the ifu, vascular perforation or dissection is an inherent risk of any electrode placement.

Event Description

During a pulmonary vein isolation procedure, a cardiac tamponade occurred.Following transseptal puncture, the flexibility ablation catheter was advanced through the introducer into the left superior pulmonary vein (lspv).When the catheter was advanced to the upper portion of the lspv, the catheter perforated into the pericardium, evidenced by patient hypotension and contrast dye noted in the pericardium.A pericardiocentesis was performed, which stabilized the patient.No further intervention was required and the patient remained stable.There were no performance issues with any sjm device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, BI-D, CURVE D-F
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5007283
• MDR Text Key: 23123779
• Report Number: 3008452825-2015-00061
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 02/15/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: A701125
• Device Catalogue Number: A701125
• Device Lot Number: 5054368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• 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: CARDIOLAB RECORDING SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 68