MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710FJ282CT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	08/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: the product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.(b)(4).Biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-03598 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # 2029046-2019-03599 for product code bd710fj282ct (webster ® cs catheter with ez steer® technology and auto id).
Event or Problem Description
It was reported that a female patient underwent an paroxysmal atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer® technology and auto id and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Post-ablation phase, cardiac tamponade was confirmed by echo as the patient¿s blood pressure dropped.Pericardiocentesis was performed to remove about 300-400 ml of fluid from the pericardial space.The patient was then moved to the operating room to close the perforation.During surgery it was found that there was a tear in the coronary sinus (cs).Patient¿s outcome is improved, the physician reported the patient was out of surgery and doing well.It is unknown if extended hospitalization was required as a result of the adverse event.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, most likely due to either the cs catheter or the ablation catheter (which was located in the right atrium near the cs) perforating the cs during several multiple cardioversions.No bwi product malfunctions were reported.Transseptal puncture was performed with a st.Jude medical brk-1 xs transseptal needle.The flow was set at 15 ml/min.No error messages were observed on any bwi equipment.An 8.5 fr.St jude agilis sheath was used with the ablation catheter.The patient received anticoagulant (heparin) during the case with an activated clotting time (act) >350 seconds.The irrigation flow setting was set at 15 ml/min.The thermocool® smart touch® sf bi-directional navigation catheter was not in close proximity to another catheter.The thermocool® smart touch® sf bi-directional navigation catheter was zeroed upon initial warm up phase post connection to the carto 3 system and was not indicated to be re-zeroed.Since the physician believed the perforation may have occurred due to either the cs catheter or ablation catheter this event will be reported under both products.
Additional Manufacturer Narrative
On(b)(6)2019 , it was discovered that the thermocool® smart touch® sf bi-directional navigation catheter (product code d134804) was inadvertently omitted from the 3500a initial mdr that was submitted to fda on (b)(6)2019.The device has now been added to section d11.Concomitant products section.Manufacturer's ref # pc-000526106.

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8964817
• Report Number: 2029046-2019-03599
• Device Sequence Number: 11415551
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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): 08/13/2019

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 Catalogue Number: BD710FJ282CT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8.5 FR. ST JUDE AGILIS SHEATH; CARTO 3 SYSTEM; ST. JUDE BRK-1 XS NEEDLE; THMCL SMTCH SF BID, TC, F-J
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 65 YR