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

Catalog Number UNK_C3 INTERFACE CABLE - THERA

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

Information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#: (b)(4).

Event Description

It was reported a patient underwent a cardiac ablation procedure wherein an unspecified mapping/ablation catheter cable was used and a loss of all ecg signals occurred.It was reported a transient signal loss occurred on the carto 3 system and the ep recording system while the catheter was inside the patient¿s body.They disconnected and reconnected all cables and changed the ecg cable without resolution.The issue was resolved by replacing the unspecified mapping/ablation extension cable.It is apparently a common technical issue caused by the sterilizable cables.The issue was solved once the cable replaced.There was no patient consequence.The physician did not have other signals to monitor the patient¿s heart rate, as such the loss of ecg signals is considered an mdr reportable malfunction.This report will be reported against this carto® 3 system interface cable.

• Brand Name: CARTO 3 SYSTEM INTERFACE CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11141200
• MDR Text Key: 232594883
• Report Number: 2029046-2021-00014
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_C3 INTERFACE CABLE - THERA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1