MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) CARTO® 3 SYSTEM INTERFACE CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1286-03-S

Device Problems Bent (1059); Failure to Deliver Energy (1211); Communication or Transmission Problem (2896); Temperature Problem (3022); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a c3 interface cable ¿ therapeutic, and a bad no ecg all channels ¿ bs and ic issue occurred.It was reported that the stockert 70 system was clicking and the temperature was going up and down.All ecg¿s were noisy.The noise started when the redel cable was plugged into the patient interface unit (piu).The redel cable and the ablation adapter were replaced without resolution.There was no catheter plugged into the ablation cable that is plugged into the piu.When the c3 interface cable-therapeutic was removed, the noise went away and there was no longer any temperature on the stockert, as it should be.The c3 interface cable-therapeutic was reprocessed many times.A new cable was plugged in and the issue was resolved.The procedure was continued without patient consequence.Upon request, additional information was provided on the event.The noise was observed on all the body surface (bs) and intracardiac (ic) channels on both the carto system and the pruka recording system and there was no signal available to monitor the patient¿s heart rhythm.The issue was a bent pin in the ablation socket.It was in contact with the pin next to it.Once it was replaced, the issue was resolved.The temperature issue was found before use.No energy could be delivered since there was no ablation catheter connected to the stockert generator.Values were not checked at the time of the issue as there was no ablation catheter.The stockert generator was programmed with the default values for the 8mm catheter.Since the noise affected all ic and bs signals on both the carto system and the pruka recording system and there was no signal available to monitor the patient¿s heart rhythm, this event is indicative of a reportable event.

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Manufacturer's ref.(b)(4).

• Brand Name: CARTO® 3 SYSTEM INTERFACE CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4233109
• MDR Text Key: 5060521
• Report Number: 9673241-2014-00465
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1286-03-S
• Device Catalogue Number: CR3434CT
• Device Lot Number: UNKNOWN_D-1286-03-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1