MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY OPTIMA DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

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

Patient Problems Nerve Damage (1979); Transient Ischemic Attack (2109); Cardiac Perforation (2513); Retroperitoneal Hemorrhage (4483)

Event Type  Injury  

Manufacturer Narrative

Concomitant device(s): tacticath se, flexibility, advisor hd grid.The reported event of cardiac tamponade, pericarditis, retroperitoneal hematoma, acute paralytic gastric dilatation, transient ischemic attack/brain infarction, and transient diaphragmatic paralysis could not be confirmed.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 incident could not be conclusively determined.

Event Description

Related manufacturing ref: (b)(4).The following was published in wiley: the journal of arrhythmia titled, "importance of the length of the myocardial sleeve in the superior vena cava in patients with atrial fibrillation" by eiji nyuta, et al: out of 427 patients, in 12 (2.8%), the complications associated with procedure, including 5 (1.2%) cardiac tamponade, 2 (0.5%) pericarditis, 2 (0.5%) retroperitoneal hematoma, 1 (0.2%) acute paralytic gastric dilatation, 1 (0.2%) transient ischemic attack/brain infarction, and 1 (0.2%) transient diaphragmatic paralysis, were observed.

• Brand Name: INQUIRY OPTIMA DIAGNOSTIC CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11330033
• MDR Text Key: 232149779
• Report Number: 2030404-2021-00012
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/15/2021
• 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