MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM INTERFACE CABLE

Model Number	CY1212CT
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record evaluation was performed for the finished device 30695815l number, and no internal action related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system interface cable.The package was open and not sealed.It was reported that when they went to open the new system interface cable, the packaging was not sealed.The cable was replaced, and the procedure continued.No picture of the packaging is available.No adverse patient consequence was reported.The open pouch seal issue was assessed as a mdr reportable product malfunction.

• Brand Name: CARTO® 3 SYSTEM INTERFACE CABLE
• Common Device Name: INTERFACE CABLE
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14519305
• Report Number: 2029046-2022-01141
• Device Sequence Number: 20205668
• Product Code: DQK
• UDI-Device Identifier: 10846835003925
• UDI-Public: 10846835003925
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Model Number: CY1212CT
• Device Catalogue Number: CY1212CT
• Device Lot Number: 30695815L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF BID, TC, D-F; UNK BRAND CABLE; UNK BRAND CATHETER; UNK BRAND CATHETER; UNK_CARTO 3
• Patient Sex: Unknown