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

Model Number	D135304
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient (female, (b)(6)) underwent cardiac ablation procedure for paroxysmal atrial fibrillation with webster cs catheter with auto id technology and suffered cardiac tamponade requiring pericardiocentesis.It was reported that while performing a transseptal puncture, the patient coughed deeply.The caller reset visualization, and the procedure was continued.The physician continued with transeptal access.The caller told the physician that they were having trouble seeing the transseptal sheath, and was advising on the structures that were seen on intracardiac echo (ice).Caller did not advise the physician of where to perform the transseptal puncture.The caller noted a drop in blood pressure, and alerted the staff.The physician then noted a large effusion on ice.Ablation procedure was aborted.The patient was transported to the operation room for a pericardial window.Patient is in stable condition at this time.Sl1 sheath used for ts access, with a brk 71cm needle.Biosense products that were in use were soundstar and cs catheters in the body, pentaray opened but not inserted.The physician stated that the deep cough may have caused the event.No ablation was performed.The patient was under general anesthesia for a couple of hours.No report of extended hospitalization.Although there is strong possibility that the tamponade was caused by the transseptal device, since the webster cs catheter with auto id technology was inserted the event is conservatively reported under this device.The possibility that the vent was caused by the soundstar is remote.Since this event may be life threatening it is mdr-reportable.
Additional Manufacturer Narrative
On 5/21/2021, the product investigation was completed as the device was not returned.It was reported that a patient (female,, in her 70-s) underwent cardiac ablation procedure for paroxysmal atrial fibrillation with webster cs catheter with auto id technology and suffered cardiac tamponade requiring pericardiocentesis.It was reported that while performing a transseptal puncture, the patient coughed deeply.The caller reset visualization, and the procedure was continued.The physician continued with transeptal access.The caller told the physician that they were having trouble seeing the transseptal sheath, and was advising on the structures that were seen on intracardiac echo (ice).Caller did not advise the physician of where to perform the transseptal puncture.The caller noted a drop in blood pressure, and alerted the staff.The physician then noted a large effusion on ice.Ablation procedure was aborted.The patient was transported to the operation room for a pericardial window.Patient is in stable condition at this time.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30451715m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 11103328
• Report Number: 2029046-2020-02046
• Device Sequence Number: 19776606
• Product Code: DRF
• UDI-Device Identifier: 10846835009989
• UDI-Public: 10846835009989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 10/12/2023
• Device Model Number: D135304
• Device Catalogue Number: D135304
• Device Lot Number: 30451715M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 05/21/2021
• 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: BRK 71CM TRANSSEPTAL NEEDLE; PENTARAY; REPROCESSED SOUNDSTAR ECO; SL SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention