MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRANSSEPTAL NEEDLE, BRK SERIES

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

Patient Problem Stroke/CVA (1770)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported cerebral vascular accident remain unknown.

Event Description

Related manufacturing ref: 3005334138-2019-00375, 3005334138-2019-00376, 3005334138-2019-00377 during an ablation procedure, a cerebral vascular accident (cva) occurred.The patient experienced diplopia and difficulty of movement.A cranial ct scan was performed with symptoms lasting less than 24 hours which resolved without sequelae.There were no performance issues with any abbott devices.The patient has a history of cva¿s with a hemorrhagic stroke in 2015 with paresis in the lower left extremity.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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; 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: 8800264
• MDR Text Key: 151360791
• Report Number: 3008452825-2019-00331
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072278
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2019
• 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
• Treatment: ADVISOR¿ HD GRID CATHETER, SE; FLEXABILITY ABLATION CATHETER; INTRODUCER
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 100