MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ INTRODUCER, UNKNOWN; TRANSSEPTAL CATHETER INTRODUCER

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

Patient Problems Stroke/CVA (1770); Fistula (1862); Hematoma (1884); Pneumonia (2011); Cardiac Perforation (2513); Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

Concomitant device: inquiry¿ steerable ep catheter.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incidents remain unknown.

Event Description

Related manufacturing ref: 2030404-2020-00096.The following was published in the journal of cardiovascular electrophysiology published by wiley periodicals titled ¿outcome after tailored catheter ablation of atrial tachycardia using ultra-high-density mapping" by christiane jungen md; jungen c, akbulak r, kahle a-k, et al; doi: 10.1111/jce.14703, july 2020.Among 342 procedures in 250 patients the following complications occurred: 3 cerebral embolic events, 3 pericardial effusions, 1 postprocedural persistent av block, 1 pneumonia following intraprocedural aspiration, 10 groin complications and 5 femoral arteriovenous fistulas.

• Brand Name: SWARTZ INTRODUCER, UNKNOWN
• Type of Device: TRANSSEPTAL CATHETER INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10840261
• MDR Text Key: 216319492
• Report Number: 3005334138-2020-00575
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052644
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: 11/02/2020
• 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