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

Catalog Number	CR3434CT
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was discarded; therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference #: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system interface cable and an issue of inadvertent pacing occurred.It was described that the carto® 3 system was displaying noise on the electrocardiogram (ecg) signals.It was also reported the ablation catheter and the catheter connected to the 20a port were displaying pacing despite no pacing being active and no pacing channels being open.All cables were disconnected from the patient interface unit (piu) and both the patient interface unit (piu) and workstation were rebooted.The patient interface unit (piu) booted up normally.When the ablation cable was connected to the patient interface unit (piu) all ecg signals were lost, however, once disconnected from the patient interface unit (piu), the ecg signal returned.The customer was advised to replace the carto® 3 system interface cable and then the issues resolved.The procedure was continued.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The customer¿s reported issue of inadvertent pacing is considered a reportable event.The issue of partial loss of ecg signals is considered a not reportable event as the risk to the patient is low.

• Brand Name: CARTO® 3 SYSTEM INTERFACE CABLE
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8473543
• Report Number: 2029046-2019-02917
• Device Sequence Number: 1515285
• Product Code: DQK
• UDI-Device Identifier: 10846835003871
• UDI-Public: 10846835003871
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: CR3434CT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1