MAUDE Adverse Event Report: ZONARE MEDICAL SYSTEMS, INC VIEWMATE¿ Z TRANSDUCER; SYSTEM, SIGNAL ISOLATION

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Event Description

Following an atrial fibrillation (af) procedure, a gastroscopy revealed the patient had experienced esophageal necrosis.2d fluoroscopy revealed the necrosis was not localized to just the place where the probe was placed.The temperature cutoff on the probe was unknown.It was noted that the tee probe was removed before the start of the procedure, since the probe was only used for transseptal puncture.The settings during ablation were 30w at the posterior wall and 35w at the anterior wall done by point-by-point ablation with a carto system (biosenes).It was noted that a termocool smart touch* sf ablation catheter was used during the procedure.A few days following the procedure after close tracking via gastroscopy, the patient made a full recovery and is currently in stable condition.Additionally, there were no known patient comorbidities that could have caused or contributed to the reported event.

Manufacturer Narrative

The device was not returned for analysis.Review of the provided field service report found that the symptom was not related to viewmate z transducer.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.The reported event of esophageal necrosis remains unknown.

• Brand Name: VIEWMATE¿ Z TRANSDUCER
• Type of Device: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• Manufacturer (Section G): ZONARE MEDICAL SYSTEMS, INC; 420 north bernardo avenue; mountain view CA 94043
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12893563
• MDR Text Key: 281412745
• Report Number: 3004189859-2021-00002
• Device Sequence Number: 1
• Product Code: DRJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K151175
• 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: 02/04/2022

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: 11/08/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 02/04/2022
• 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): Other