MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH

Model Number G407209

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2015

Event Type  Injury  

Event Description

During an electrophysiology procedure, the tip of the brk transseptal needle detached inside the patient.The detached tip remains in the patient.Further information has been requested but not yet received.

Manufacturer Narrative

(b)(4).Additional information: (mfr and exp dates of multiple possible lots): lot 4993532: mfr 07mar2015, exp 28feb2018; lot 4681341: mfr 02jul2014, exp 30jun2017.The results of the investigation concluded that the brk needle had been fractured at its distal end.The fractured needle tip was not returned.No other visual anomalies were noted.The device history records for each possible batch number were reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the processes were performed and completed in accordance with sjm specifications and procedures.The cause of the reported tip detachment is consistent with forcible contact.

Event Description

During transseptal puncture to place a mitral clip, the tip of the brk transseptal needle detached during advancement through a mullins-type sheath.Initially, the needle tip was mobile in the left atrium but then traveled via the pulmonary vein to the lung.The needle tip is currently lodged in the left lower lobe of the lung and there are currently no plans for removal.

• Brand Name: BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4949674
• MDR Text Key: 6196181
• Report Number: 3005188751-2015-00088
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2015

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 Model Number: G407209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 80 YR