MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ STEERABLE EP CATHETER; ELECTROPHYSIOLOGY (STEERABLE)

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

Patient Problems Nerve Damage (1979); Cardiac Perforation (2513); Peripheral Nervous Injury (4414); Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

The following was published in the.Cardiology journal [cardiol j] 2022; vol.29 (5), pp.807-814.Date of electronic publication: 2020 nov 03, "clinical outcomes of cryoballoon ablation for pulmonary vein isolation: impact of intraprocedural heart rhythm", bruno reissmann.The current study sought to assess the impact of the intraprocedural heart rhythm (sinus rhythm [sr] vs.Atrial fibrillation [af]) on acute procedural characteristics, durability of pulmonary vein isolation (pvi) and long-term clinical outcomes of cryoballoon (cb) ablation.Methods: a total of 195 patients with symptomatic paroxysmal (n = 136) or persistent af (n = 59) underwent cb-based pvi.Ablation procedures were either performed in sr (sr group; n = 147) or during af (af group; n = 48).Persistent af was more frequent in the af group than in the sr group (62% vs.20%).All other patient baseline characteristics did not differ between the two groups.Two cardiac tamponades occurred requiring a pericardiocentesis, phrenic nerve paralysis in three patients and an arteriovenous fistula.

Event Description

Information received confirmed the inquiry catheter or any other abbott device did not contribute to the cardiac tamponades.

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 perforation remains unknown.Per the ifu, vascular perforation is an inherent risk of any electrode placement.

Event Description

It was confirmed that the inquiry catheter did not cause the tamponades.

Manufacturer Narrative

B5: additional information.H6: corrected information: health effect clinical code.

• Brand Name: INQUIRY¿ STEERABLE EP CATHETER
• Type of Device: ELECTROPHYSIOLOGY (STEERABLE)
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15809071
• MDR Text Key: 303799099
• Report Number: 2030404-2022-00071
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2023

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: 11/07/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 04/20/2023
• Supplement Dates FDA Received: 12/07/2022; 04/20/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other