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

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

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Event Description

An (b)(6)-year-old man with no structural heart disease underwent pulmonary vein isolation (pvi) for symptomatic paroxysmal atrial fibrillation (af).The pvi was successfully performed by cryoballoon ablation with a single transseptal puncture.A 12fr deflectable sheath and an 8.5fr long sheath crossed the interatrial septum via the same puncture site.Five months after pvi, the patient was readmitted because of heart failure and recurrence of af.The echocardiogram showed a large (10.7 ×5.8 mm) iatrogenic atrial septal defect (iasd) at the previous puncture site.Both right-to-left and left-to-right shunts were observed during systole and diastole, respectively.Despite the initiation of optimal medical therapy for heart failure, symptoms were not completely controlled and iasd remained 11 months after pvi.Eventually, he received multiple additional pvi for recurrence of af and percutaneous transcatheter closure (13 mm disc for 10.9 ×8.9 mm- iasd), then heart failure was controlled with the improvement of the right atrial and ventricular size.

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 incident could not be conclusively determined.Review of the device history record was not possible as the lot number is unknown.

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 incident could not be conclusively determined.Review of the device history record was not possible as the lot number is unknown.

Event Description

An (b)(6)-year-old man with no structural heart disease underwent pulmonary vein isolation (pvi) for symptomatic paroxysmal atrial fibrillation (af).The pvi was successfully performed by cryoballoon ablation with a single transseptal puncture.A 12fr deflectable sheath and an 8.5fr long sheath crossed the interatrial septum via the same puncture site.Five months after pvi, the patient was readmitted because of heart failure and recurrence of af.The echocardiogram showed a large (10.7 ×5.8 mm) iatrogenic atrial septal defect (iasd) at the previous puncture site.Both right-to-left and left-to-right shunts were observed during systole and diastole, respectively.Despite the initiation of optimal medical therapy for heart failure, symptoms were not completely controlled and iasd remained 11 months after pvi.Eventually, he received multiple additional pvi for recurrence of af and percutaneous transcatheter closure (13 mm disc for 10.9 ×8.9 mm- iasd), then heart failure was controlled with the improvement of the right atrial and ventricular size.

• Brand Name: SWARTZ¿ INTRODUCER
• 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: 13576923
• MDR Text Key: 286051309
• Report Number: 3005334138-2022-00087
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052644
• 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
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• 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: 02/01/2022
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male