MAUDE Adverse Event Report: GREATBATCH MEDICAL MOBICATH BIDIRECTIONAL GUIDING SHEATH, 1000182-001; INTRODUCER, CATHETER

Model Number 1000182-001

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

Patient Problem Heart Block (4444)

Event Type  Injury  

Event Description

Procedure started with patient in persistent atrial fibrillation.The objective of the procedure was the isolation of the pulmonary veins using carto mapping system and rf-technology.The physician used a smarttouch sf c3 uni d-curve, lasso 2515 nav eco diag.Catheter and a mobicath sheath as well as an 10-pol cs catheter (abbott).After mapping in atrial fibrillation and proper isolation of the right pulmonary veins, the physician decided for cardioversion in order to validate the isolation of the right pulmonary veins in sinus rhythm.After cardioversion the patient was in bradycardia with a heart rate of approximately 40 bpm.The physician started atrial stimulation over cs 5-6 with an initial frequency of 800ms and decreased the frequency to 1000ms and finally to 1500ms to check the hearts natural rhythm.At that time, the patient had a sufficient heart rhythm.However, the physician noticed that the patient's oxygen saturation decreased and started ventilation.In the meantime, the other physician started an echocardiography to check for pericardial effusion.According to the physician no pericardial effusion could be observed.After a few seconds an av block iii occurred spontaneously and the patients ventricles stopped beating.At this point the procedure was stopped and the physicians started reanimation of the patient.The physicians decided to implant a temporary pacemaker for cardiac stabilization.After implantation the patient was stable and will be forwarded to intensive care unit.At this time the patient was hemodynamically stable.According to the physician this adverse event is not directly linked to carto.The physician used the proper settings on the sa generator for the tc stsf catheter and used max.30w on the posterior wall and max.35 watts anterior.No errors or harmful events were observed during mapping or ablation.No allegations were made against the mobicath sheath.

• Brand Name: MOBICATH BIDIRECTIONAL GUIDING SHEATH, 1000182-001
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 12347603
• MDR Text Key: 267438387
• Report Number: 2183787-2021-00074
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1000182-001
• Device Catalogue Number: D140010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention