MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) 20 POLE ECO CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-5852-03

Device Problem Noise, Audible (3273)

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

Event Date 01/12/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a 20 pole eco cable and a noise issue occurred.When the lasso eco was connected to the carto 3 system there was noise on all of the electrograms.The catheter cable was changed which did not resolve the issue.The eco dongle cable was changed which resolved the issue and the procedure was continued.The procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since it is unknown if noise occurred on all the channels, including the 12 leads of body surface electrocardiogram (ecg) and all intracardiac ecgs on the carto and recording system, and it is also unknown if there was any ecg signal available for the physician to monitor the patient's heart rhythm, bwi conservatively reports this event.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a 20 pole eco cable and a noise issue occurred.The returned device was visually inspected and one pin was missing on p1 connector side.Then a carto 3 test was performed with the cable and a known good catheter and no malfunctions were observed.No errors or noise were displayed.All the cables are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Catheter failed during the visual inspection.However based on the available analysis finding results, the failure mode reported by the customer does not appear to be caused by any internal bwi processes; since cable pass all the functional tests.The root cause of the broken pin cannot be determined.

• Brand Name: 20 POLE ECO 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: joaquin kurz ; 9497893837
• MDR Report Key: 5414003
• MDR Text Key: 38139332
• Report Number: 2029046-2016-00005
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-5852-03
• Device Catalogue Number: EM5050060
• Device Lot Number: OEM_M-5852-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1