MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BNI35BDCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: bard sl1 8.5fr sheath (model# unknown, lot# unknown).Manufacture reference no: (b)(4).
Event or Problem Description
It was reported that a (b)(6) patient underwent an atrial fibrillation (afib) ablation procedure with an thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During ablation phase, pericardial effusion was discovered by fluoro.Cardiac tamponade was confirmed by transthoracic echo (tee).Pericardiocentesis was performed to remove 500cc of fluid from the pericardium.The patient was reported to be in stable condition after pericardial drainage.It is unknown if extended hospitalization was required as a result of the adverse event.Patient¿s outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related.There were no error messages observed on any bwi equipment during the procedure.Patient¿s relevant history includes metastatic cancer.Transseptal puncture was not performed.A bard sl1 8.5fr sheath was used during the procedure.There¿s no information regarding ablation parameters.The catheter irrigation flow ranged from 8/15ml/min.The patient did not receive anticoagulant during the procedure.
Additional Manufacturer Narrative
It was reported that a (b)(6) year-old patient underwent an atrial fibrillation (afib) ablation procedure with an thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.The bwi failure analysis lab received the device for evaluation on 10/4/2018.The investigational analysis completed on 10/29/2018.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized with no errors were observed.Electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Irrigation and deflection testing was performed and it was found within specifications.The catheter was irrigating and deflecting correctly.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture reference no: (b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7902610
• Report Number: 2029046-2018-02094
• Device Sequence Number: 11121374
• Product Code: LPB
• UDI-Device Identifier: 10846835003147
• UDI-Public: 10846835003147
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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,Followup
• Report Date (Section B): 08/30/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: BNI35BDCT
• Device Lot Number: 17725963L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 44