MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1286-03-S

Device Problems Leak/Splash (1354); Failure to Transmit Record (1521); Device Displays Incorrect Message (2591); Material Twisted/Bent (2981); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a c3 interface cable ¿ therapeutic and a noise issue occurred.The patient was not under general anesthesia.When the ablation catheter was plugged into the patient interface unit, a current leakage error and a force data streaming error occurred.There was an electrocardiogram (ecg) signal noise and signal loss when these errors occurred.The ecg noise/signal loss was on body surface and intracardiac signals as well as on the carto and recording system.There was no ecg signal available for the physician to monitor the patient¿s heart rhythm.The catheter was unplugged and the resterilized cable was changed.It was also noted that initial cable had twisted pins.The current leakage error was then resolved, but the force error remained.The catheter was changed and the force error cleared.The procedure was completed with no patient consequence.The force error is not mdr reportable because the risk to the patient is low.However, the inability to monitor the patient¿s ecg rhythm while devices are intra cardiac might lead to an undetected cardiac rhythm that could be life threatening.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6306225
• MDR Text Key: 66927193
• Report Number: 9673241-2017-00094
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• 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: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1