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

Catalog Number	D728260RT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant product: smarttouch bidirectional sf us catalog #: d-1348-04-s lot #: 30007894l.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for atypical atrial flutter with a webster catheter and suffered a cardiac tamponade requiring pericardiocentesis.During placement of the webster catheter in the coronary sinus, the physician noted resistance followed by rapid catheter advancement.After transseptal puncture and left atrial ablation, the intracardiac echocardiography (ice) catheter was repositioned to more effectively visualize the ridge between the left pulmonary veins and the left atrial appendage (laa).At this point, the right ventricular effusion was detected.Remainder of procedure was aborted.Catheters were removed from the patient.Pericardiocentesis yielded an unspecified volume of fluid.Patient remained asymptomatic and stable throughout the procedure.Patient was transferred for observation.Patient required extended hospitalization (overnight) as a result of the adverse event for monitoring of the effusion.Patient fully recovered.Factors cited that may have contributed to the adverse event include that the physician pushed against the resistance of the coronary sinus valve.Physician¿s opinion regarding the cause of the adverse event is that a perforation occurred during positioning of the webster catheter in the coronary sinus, prior to transseptal puncture.Transseptal puncture was performed with an unspecified needle and an unspecified sheath.Generator was set on standard parameters (unspecified).Generator settings at the time of injury included power at 25 watts, temperature of 34 degrees celsius, and impedance of 125 ohms.Power was not titrated during the procedure.There is no information regarding overall ablation time or last ablation cycle time at the site of injury, as ablation was not suspected to be the cause of the adverse event.Irrigated catheter flow was set on smarttouch sf settings (unspecified).Patient received anticoagulant during the procedure with activated clotting time (act) maintained between 300-350 seconds.There is no information regarding shaft proximity interference value.Smarttouch bidirectional sf catheter was not in close proximity to another catheter.Smarttouch bidirectional sf catheter was zeroed after the initial warm-up phase post catheter connection to the carto 3 patient interface unit.Carto 3 system did not indicate to re-zero the catheter.There were no issues or errors reported on any biosense webster, inc.Products or equipment during the procedure.

• Brand Name: WEBSTER
• 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: 7564149
• Report Number: 2029046-2018-01631
• Device Sequence Number: 16647229
• Product Code: DRF
• UDI-Device Identifier: 10846835004960
• UDI-Public: 10846835004960
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K953663
• 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
• Report Date (Section B): 05/07/2018

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 Catalogue Number: D728260RT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/03/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR