MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM

Model Number 407200

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

Patient Problems Death (1802); Cardiac Perforation (2513)

Event Date 07/09/2014

Event Type  Death  

Event Description

Related manufacturer reference 3005188751-2014-00084, 3005188751-2014-00089, 2030404-2014-00077, 2030404-2014-00078, 2030404-2014-00079, 2184149-2014-00005.Following a ventricular tachycardia (vt) ablation procedure, the patient expired.This high risk substrate modification vt ablation procedure in the left ventricle was performed on an elderly male with severe cardiomyopathy, a history of large lad territory myocardial infarction, and an implanted cardiac pacemaker/defibrillator.The patient presented to the lab in a paced rhythm and anesthesia was administered; the patient subsequently became hypotensive.An epinephrine infusion was initiated to stabilize and maintain blood pressure.Transseptal puncture was performed with transesophageal echocardiogram guidance using a brk transseptal needle and an agilis nxt introducer was advanced into the left atrium.Following the transseptal puncture, a pericardial effusion was noted; however, this was not significant and the procedure continued.A non-sjm screw in bipolar pacing catheter was placed in the right ventricle and an inquiry afocus ii ep catheter was advanced into the left ventricle.The afocus ii ep catheter was used to map, both transseptal and via a retrograde approach.The afocus ii ep catheter was damaged and then replaced to continue mapping.During completion of the map, the patient developed vt, resulting in hemodynamic instability; therefore, the patient was cardioverted to sinus rhythm (sr).The catheters shifted on the ensite velocity mapping system due to the cardioversion and settings changes.Re-mapping was completed and the afocus ii ep catheter was replaced with a tacticath quartz ablation catheter.Catheter display issues were noted and troubleshooting was performed, eventually resolving this issue.Re-mapping was performed again using a therapy cool flex ablation catheter.Ablation was successfully performed around a very large scar which stretched from the apex to the base of the left ventricle.Near the conclusion of the procedure, the anesthesia team noted it was difficult to maintain a stable blood pressure and the pericardial effusion noted earlier had increased in size.Protamine was administered and a pericardial drain was placed, which stabilized the patient's blood pressure.The patient was awakened and transferred to the recovery room in stable condition.The patient then became hypotensive and an epinephrine bolus was administered.An echocardiogram revealed an effusion with no left ventricular movement.The patient subsequently expired.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our analysis 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 death could not be conclusively determined.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4023638
• MDR Text Key: 4882527
• Report Number: 3005188751-2014-00088
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 407200
• Device Lot Number: 4453239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: INQUIRY AFOCUS II EP CATHETER: 87008/4480244; NON-SJM SCREW IN BIPOLAR PACING CATHETER:; A088017/4422488; PN-004075/30945; 85809, LOT UNK; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER:; AGILIS NXT INTRODUCER: G408332/4203671; THERAPY COOL FLEX ABLATION CATHETER:; PN-004075/30938; 407356/4567292; ENSITE VELOCITY MAPPING SYSTEM; CARDIAC ABLATION GENERATOR CONNECTING CABLE:; TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER:; TACTICATH QUARTZ CONTACT FORCE ABLATION CATHETER:; INQUIRY AFOCUS II EP CATHETER: 87008/4435466; MODEL UNK, LOT UNK
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 71 YR