MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D135303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	05/13/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.A manufacturing record evaluation was performed for the finished device 30126551m number, and no internal actions related to the reported complaint condition were identified.(b)(6).(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a webster cs catheter with auto id technology and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and death.After femoral vein puncture, the soundstar eco 8fg ultrasound catheter was inserted into the patient¿s body and several contours of the left atrium and right atrium were acquired.After that, transseptal puncture was performed, and the webster cs catheter with auto id technology was inserted.At that time during the ablation phase, the patient became hypotensive, and cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of arterial blood from the pericardial space; however, the bleeding could not be stopped, and thoracotomy was performed.The patient appeared to be in stable condition; however, the patient died after they were transferred to the intensive care unit (icu).Physician¿s opinion regarding the cause of the death is that it occurred due to the cardiac tamponade that occurred by injury to the left atrium during transseptal puncture and that there¿s no relationship between the death and the bwi products.No error messages were observed on any bwi equipment during the case.Despite the physician attributing the causality of the adverse event to an injury to the left atrium during the transseptal puncture, it cannot be confirmed the injury was not caused by the biosense webster inc.Catheter; therefore, this event it is to be attributable to the webster cs catheter with auto id technology.
Additional Manufacturer Narrative
On 6/5/2019, after submission of the 3500a initial mdr, it was noticed that the concomitant devices were inadvertently omitted from the 3500a initial mdr.They have now been added to section d11.Concomitant medical products.Manufacturer's ref # (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8672344
• Report Number: 2029046-2019-03233
• Device Sequence Number: 11347996
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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 Expiration Date: 10/01/2021
• Device Catalogue Number: D135303
• Device Lot Number: 30126551M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/05/2019
• 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: CARTO3 EXTERNAL REFPATCH 6PACK; COOLFLOW TUBING SET,SINGLE PK; SOUNDSTAR ECO SMS 8F CATHETER
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 65 YR