MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) BRK-1¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH

Model Number 407207

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

Patient Problem Cardiac Perforation (2513)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the information received, the cause of the reported incident could not be conclusively determined and the device was not received for evaluation.A review of the device history record was not possible since the batch number was unavailable.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Same mfr report as 9680001-2016-00063.During an ablation procedure, a pericardial effusion occurred.The cause of the perforation is unknown as transseptal puncture was difficult and while conducting a mitral valve isthmus ablation in the left atrium, a steam pop was heard.The patient's blood pressure dropped after the steam pop occurred, trans-thoracic echocardiogram (tte) was performed and a perforation was noted, however the location of the perforation is unknown.A pericardiocentesis was performed and the patient was stable.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 98 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA (AFD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5868270
• MDR Text Key: 51847243
• Report Number: 3008452825-2016-00108
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK072278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2016

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: Physician
• Device Model Number: 407207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: FAST CATH, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70