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

Model Number 407201

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

Patient Problem Cardiac Perforation (2513)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

No product was returned for investigation. a review of the device history record was not possible since the batch number is unavailable.Based on the information provided to abbott, the reported pericardial effusion could not be confirmed.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference: 9680001-2019-00071, 3005334138-2019-00236, 3005334138-2019-00237, 2182269-2019-00050.During a paroxysmal atrial fibrillation radiofrequency ablation procedure, an effusion occurred.During ablation of the anterior roof of the left superior pulmonary vein antrum, contact and stability were difficult.The catheter was then positioned on the coumadin ridge and ablation was started.The patient became hypotensive and ablation was ceased.The ice catheter was used to scan for the pericardial effusion and located.Heparin was stopped and a pericardiocentesis was performed.The patient was followed and stable.The cause of the perforation is unknown.There were no performance issues with any abbott device.

• Brand Name: BRK-1¿ TRANSSEPTAL NEEDLE, 71 CM LENGTH
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8563235
• MDR Text Key: 143523483
• Report Number: 3008452825-2019-00218
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

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: 407201
• Device Catalogue Number: 407201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 04/29/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR