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

Model Number D-1286-01-S

Device Problems High Readings (2459); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the customer got high force reading and the signal noise occurred on all the channels, including the 12 leads of bs and all ic (intracardial) recordings on both carto and the recording system at the same time.The issue occurred while preparing to ablate.The customer had finished connecting the left veins and had this issue pop up when going to the right sided pulmonary veins.When they went to the right side and had one high force reading and it appeared as if the catheter was visually flipping across the screen on carto and the physical manipulation of the catheter.Replacing the catheter cable, rebooting the piu and changing the catheter did not resolve the issue.The procedure was completed with changing out the catheter cable again without any patient consequence.

Manufacturer Narrative

Manufacturer ref # (b)(4) are related to the same event.The concomitant products: carto 3 system model # m-4800-01, serial # (b)(4); smart touch bidirectional model# d-1327-05-s, lot # 16107500m.

• Brand Name: CARTO® 3 SYSTEM INTERFACE CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 3957702
• MDR Text Key: 4626522
• Report Number: 2029046-2014-00212
• 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: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1286-01-S
• Device Catalogue Number: CB3434CT
• Device Lot Number: OEM_D-1286-01-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1