MAUDE Adverse Event Report: TZ MEDICAL, INC; CATHETER

Catalog Number CF-D7-AAA-NSDA

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 09/23/2014

Event Type  No Answer Provided  

Event Description

During cardiac ablation, sudden decrease in blood pressure and heart motion compared to baseline.Pericardial effusion confirmed and resolved with subsequent pericardiocentesis.

• Type of Device: CATHETER
• Manufacturer (Section D): TZ MEDICAL, INC; 17750 sw upper boones ferry rd; portland OR 97224
• MDR Report Key: 4411810
• MDR Text Key: 5417494
• Report Number: 4411810
• Device Sequence Number: 1
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/30/2014
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Device Catalogue Number: CF-D7-AAA-NSDA
• Device Lot Number: 0216108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 71 YR
• Patient Weight: 75