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

Model Number D-1353-03-S

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

During an idiopathic ventricular tachycardia procedure, it was reported that there was noise on all ecg channels (intracardiac and ablation) on the carto 3 and the recording system and an ¿ecg disconnected¿ error displayed on the carto 3 system.The ecg patch connections were checked and the ablation cable was exchanged with a new one with no resolution.The issue was resolved by exchanging the webster cs catheter with auto id technology to a thermocool® sf nav uni-directional catheter and the case resumed.Long after the catheter was exchanged to a thermocool® sf nav uni-directional catheter, the patient¿s blood pressure dropped after going transseptal and an intracardiac echocardiography (ice) confirmed a pericardial effusion.A pericardiocentesis was performed and 250 cubic centimeters (cc) of fluid was removed.The patient was stabilized and under observation.On (b)(4), received additional information requested from bwi representative stating that the noise occurred on all channels, including the 12 leads of body surface and intracardiac signals, on both systems at the same time.The physician was not capable of interpret the signals and therefore, proceeded to exchange the catheter.The issue was resolved and able to continue with the procedure.Due to this additional information received, this complaint became reportable.Awareness date changed from (b)(6) 2014.

Manufacturer Narrative

(b)(4), are related to the same event.The report for the pericardial effusion will be documented and submitted under (b)(4); while for the noise signals malfunction will be documented and submitted under (b)(4).Concomitant bwi products: product: carto® 3 system, us catalog # fg540000, serial # (b)(4).Product: stockert 70 rf generator: us catalog # s7001, serial # (b)(4).Product: coolflow® irrigation pump: us catalog # cfp002, serial # (b)(4).Product: soundstar® 3d diagnostic ultrasound catheter: us catalog # sndstr10g, lot # g3017624.Product: pentaray nav high-density mapping catheter: us catalog # d128204, lot # unknown.Product: thermocool® sf nav uni-directional catheter: us catalog # d131503, lot # unknown.(b)(4).

Manufacturer Narrative

A) multiple attempts have been made to request for the complaint product to be returned for analysis.Product was not returned for investigation as initially reported.(b)(4).

• Brand Name: WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3662832
• MDR Text Key: 4198812
• Report Number: 2029046-2014-00066
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2013
• Device Model Number: D-1353-03-S
• Device Catalogue Number: D135303
• Device Lot Number: UNKNOWN_D-1353-03-S
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1