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

Model Number 407200

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

Patient Problem Cardiac Perforation (2513)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding the event were requested but not received.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: 3005334138-2019-00499, 2182269-2019-00159, 3008452825-2019-00456, 3005334138-2019-00500, 9680001-2019-00121.During an atrial fibrillation procedure, a pericardial effusion occurred.During the procedure, the physician noted reduced ventricular contractility and the patient became hypotensive.Utilizing an ice catheter, a pericardial effusion was confirmed.The procedure was discontinued and a pericardiocentesis was performed.Heparin was reversed with iv protamine.The patient was observed in the procedure lab for approximately 40 minutes with no further fluid noted and discharged in a stable condition.

• Brand Name: BRK¿ 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: 8977827
• MDR Text Key: 157032033
• Report Number: 3008452825-2019-00455
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 407200
• Device Catalogue Number: 407200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2019
• 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: 74 YR
• Patient Weight: 88