MAUDE Adverse Event Report: ST. JUDE MEDICAL TRANSSEPTAL NEEDLE, BRK SERIES

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); Cardiac Perforation (2513); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The following was published in heart 109.12: 921-928.Bmj publishing group.(jun 1, 2023) "impact of pre-existing left atrial appendage occluder on catheter ablation of atrial fibrillation" jien-jiun chen.From our atrial fibrillation registry, 65 drug-refractory patients with laao (left atrial appendage occlusion) were included for pulmonary vein isolation.A balanced control group with 124 patients without laao receiving pulmonary vein isolation were included for comparison.The rate of procedure-related pericardial effusion was similar between the two groups with 5 total.There were 3 periprocedural strokes.In these two patients with periprocedural stroke, the possibility that the catheter touched the occluder device and caused microthrombus embolization could not be ruled out.Therefore, it was proposed not to touch the device as much as possible by using a computed tomography and 3d mapping merge to guide the exact location of the occluder when ablating the left-sided pulmonary vein, or in carto, the ct could be used to guide the ablation.

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 incident could not be conclusively determined.

Event Description

The following was published in heart 109.12: 921-928.Bmj publishing group.(jun 1, 2023) "impact of pre-existing left atrial appendage occluder on catheter ablation of atrial fibrillation" jien-jiun chen.From our atrial fibrillation registry, (b)(4) drug-refractory patients with laao (left atrial appendage occlusion) were included for pulmonary vein isolation.A balanced control group with (b)(4) patients without laao receiving pulmonary vein isolation were included for comparison.The rate of procedure-related pericardial effusion was similar between the two groups with (b)(4) total.There were (b)(4) periprocedural strokes.In the two patients with periprocedural stroke, the possibility that the catheter touched the occluder device and caused microthrombus embolization could not be ruled out.Therefore, it was proposed not to touch the device as much as possible by using a computed tomography and 3d mapping merge to guide the exact location of the occluder when ablating the left-sided pulmonary vein, or in carto, the ct could be used to guide the ablation.The physician does not allege that the advisor hd grid catheter or brk transseptal needle caused or contributed to the procedure-related pericardial effusions or periprocedural strokes.

• Brand Name: TRANSSEPTAL NEEDLE, BRK SERIES
• Type of Device: TRANSSEPTAL NEEDLE
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17238995
• MDR Text Key: 318207729
• Report Number: 3008452825-2023-00285
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K072278
• 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
• Report Date: 07/17/2023

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: 06/12/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/17/2023
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other