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

Model Number CB3410CT

Device Problems Product Quality Problem (1506); Contamination /Decontamination Problem (2895)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system interface cable.There was dirt in the package.When removing the material from the box (external packaging), it was observed that the material itself had a dirt compared to the paint, being considered as contaminated.The (transparent) inner packaging was intact and was not opened for correct analysis of what happened.I emphasize that the "ink" was in the material, and the inner packaging had not been broken.No patient consequences.Cosmetic damage is not mdr-reportable.Foreign material inside of the packaging is mdr-reportable.

Manufacturer Narrative

On (b)(6)2021, the bwi product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

On 28-feb-2022, the product investigation was completed.It was reported that an unknown patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system interface cable.There was dirt in the package.When removing the material from the box (external packaging), it was observed that the material itself had a dirt compared to the paint, being considered as contaminated.The (transparent) inner packaging was intact and was not opened for correct analysis of what happened.I emphasize that the "ink" was in the material, and the inner packaging had not been broken.No patient consequences.Device evaluation details: the device was visually inspected and foreign material was observed on the pouch of the device.A manufacturing investigation was performed and it was concluded that this issue is related to the manufacturing process since it was found lack of standardization in epoxy application procedure.A manufacturing record evaluation was performed for the finished device 30413358l number, and no internal action was found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following instructions: the cable should be visually inspected for any damage (i.E.Cuts, kinks, nicks, crushed or elongated sections) prior to use or reuse.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 12-apr-2022, bwi had also analyzed photos of the received device.According to pictures provided by the customer, a foreign material was observed in the pouch.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO® 3 SYSTEM INTERFACE CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; 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: 12457949
• MDR Text Key: 271055427
• Report Number: 2029046-2021-01535
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835003789
• UDI-Public: 10846835003789
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: CB3410CT
• Device Catalogue Number: CB3410CT
• Device Lot Number: 30413358L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/12/2021
• Supplement Dates Manufacturer Received: 10/14/2021; 02/28/2022; 04/12/2022
• Supplement Dates FDA Received: 11/02/2021; 03/21/2022; 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2021
• 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