MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DUODECA CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D728260RT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	07/28/2021
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 (b)(6) female patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported by the caller that the patient suffered a pericardial effusion in the middle of the procedure- this was before any ablation had been performed.The patient became hypotensive before the ablation catheter (4mm df curve) had been inserted, and then an effusion was seen on tte (transthoracic) imaging.A pericardiocentesis was performed, with approximately 200 ml of fluid removed, with a drain left in place.The patient was stabilized, and the procedure was continued and completed.The patient is currently stable.This adverse event was discovered during use of bwi products.The physician¿s opinion on the cause of this adverse event: md said it could have been a wire or the duodeca catheter (60mm spacing).Patient outcome of the adverse event was unknown.Extended hospitalization because of the adverse event is unknown.A transseptal puncture was not performed.Prior to noting the ct ablation was not performed.No evidence of steam pop.The event occurred during mapping phase.No irrigated catheter was used.No error messages observed on biosense webster equipment during the procedure.The patient is hemodynamically stable at this time of the report.The effusion was discovered/noticed: patient was hypotensive.Suspected perforation: unknown.It was it confirmed: transthoracic echo.Max wattage used: 50w, total lesions: 9, total ablation time: 2m 42 s, the procedure was completed after the pericardiocentesis.It is life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
Additional Manufacturer Narrative
On (b)(6) 2021, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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: DUODECA CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12323362
• Report Number: 2029046-2021-01351
• Device Sequence Number: 14496362
• Product Code: DRF
• UDI-Device Identifier: 10846835004960
• UDI-Public: 10846835004960
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K953663
• 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): 07/28/2021

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 Model Number: D728260RT
• Device Catalogue Number: D728260RT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: EZ STEER NAV; EZ STEER NAV
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 56 YR