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

Model Number G407208

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/17/2014

Event Type  Injury  

Event Description

Related mfr reference 3005188751-2014-00050.During an electrophysiology procedure, a cardiac perforation occurred.A transseptal puncture was performed with a brk transseptal needle and a swartz braided transseptal introducer.The needle was removed and a guidewire was advanced through the introducer, however, it was noted on fluoroscopy the guidewire was located in the pericardium instead of the left atrium.A transesophageal echocardiogram confirmed a pericardial effusion.The procedure was aborted at this time and, due to the size of the effusion, no further intervention was required.The pt was stable.There were no performance issues with any sjm device.

Manufacturer Narrative

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 mfg and inspection operation was performed and indicated complete in accordance with sjm specs and procedures.Based on the info received, the cause of the reported cardiac tamponade was procedure related.Per the ifu, cardiac perforation is an inherent risk of the transseptal technique.

• Brand Name: TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM
• Manufacturer (Section D): ST. JUDE MEDICAL (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east county road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3763503
• MDR Text Key: 16014097
• Report Number: 3005188751-2014-00051
• 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: 03/17/2014

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: 11/30/2016
• Device Model Number: G407208
• Device Lot Number: 4386224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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: SWARTZ BRAIDED TRANSSEPTAL INTRODUCER:; (B)(4); INQUIRY EP QUADRIPOLAR CATHETER: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR