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 Problem Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

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 pseudoaneurysms could not be conclusively determined.

Event Description

The following was published in the imr press, review in cardiovascular medicine: influence of excess weight and obesity on performance and outcome of pulmonary vein isolation with the cryoballoon by blockhaus, christian et al: september 2021.A pulmonary vein isolation (pvi) study was conducted to investigate the safety and feasibility of pvi procedures for patients that are overweight or obese.A total of 228 patients were observed with all pulmonary veins noted to be successfully isolated.Two pseudoaneurysms were observed which required no intervention.

• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12836455
• MDR Text Key: 280959332
• Report Number: 3005334138-2021-00692
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 11/08/2021
• 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