MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	NS7TCD8L174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed. a manufacturing record evaluation was performed for the finished device 30108659m number, and internal action was found during the review.Concomitant products: non biosense webster, inc.- st.Jude medical sl-2 transseptal sheath; non biosense webster, inc.¿ st.Jude medical brk transseptal needle.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a female patient in their mid-eighties underwent an atrial fibrillation (afib) ablation procedure with a navistar¿ ds electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, there was a drop-in patient¿s blood pressure.Cardiac tamponade was confirmed by echo.Pericardiocentesis was performed to remove 250 cc of fluid from the pericardium.Blood transfusion was also performed.The patient was reported to be in stable condition after pericardial drainage.The patient stayed overnight in the intensive care unit (icu).Patient¿s outcome is fully recovered.Patient¿s anatomy was cited as a factor that might have contributed to the adverse event (large patient).Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, the physician assumed the event occurred during the ablation.No error messages were observed on any biosense webster, inc.Equipment during the procedure.Transseptal puncture was performed with a st.Jude medical sl-2 transseptal sheath and a brk transseptal needle.A st.Jude medical sl-2 8fr sheath was used during the case.The generator was being used in temperature control mode wat the time of the injury, the settings included 60 watts, 55 degrees and 40 seconds.The impedance varied from 92-106 ohms.The total number of ablations done was 108.The patient received anticoagulant (unspecified) with an activated clotting time (act) range between 300-350 seconds.

• Brand Name: NAVISTAR¿ DS ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8463027
• Report Number: 2029046-2019-02901
• Device Sequence Number: 16191195
• Product Code: OAD
• UDI-Device Identifier: 10846835000580
• UDI-Public: 10846835000580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2021
• Device Catalogue Number: NS7TCD8L174HS
• Device Lot Number: 30108659M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88