MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MANNETONKA) TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM

Model Number G407209

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pericardial Effusion (3271)

Event Date 01/03/2014

Event Type  Injury  

Event Description

Related manufacturer reference 2030404-2014-00010, 3005188751-2014-00013.During an atrial fibrillation ablation procedure, a pericardial effusion occurred.Transseptal puncture was performed with a brk transseptal needle and a reflexion spiral hd catheter was placed in the left atrium.While ablation was being performed along the mitral isthmus with the therapy cool path duo ablation catheter, the patient became hypotensive.A pericardial effusion was confirmed via fluoroscopy and an echocardiogram.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.

Manufacturer Narrative

Method: the results of the investigations 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 rec'd, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known inherent risk during the use of this device.

• Brand Name: TRANSSEPTAL NEEDLE, XS, BRK-1, 71CM
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MANNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east country road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3629039
• MDR Text Key: 4208953
• Report Number: 3005188751-2014-00012
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2014

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: 09/30/2016
• Device Model Number: G407209
• Device Lot Number: 4305566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: (88008/4298634); THERAPY COOL PATH DUO ABLATION CATHETER,; REFLEXION SPIRAL HD CATHETER (401661/4310183); CATHETER CONNECTING CABLE (85644/4045205); (407449/4241939); FAST CATH INTRODUCER (406188/4296991); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER,; INQUIRY EP DECAPOLAR CATHETER (81101/4200023)
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 90