MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STERILE INTERFACE CABLE; SEE H11

Catalog Number	D133701
Medical Device Problem Codes	Communication or Transmission Problem (2896); Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D2a.Common device name: percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation the bwi product analysis lab received the device for evaluation 22-mar-2026.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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) procedure with a sterile interface cable and a signal interference (noise/loss) issue observed on the ic, bs, or all ecg (bs + ic) channels on all systems and the ekg became unavailable for the physician to monitor the patient¿s heart rhythm.Initially it was reported that there was a "current leak" alert being displayed on the trupulse¿ monitor.They replaced the varipulse¿ catheter cable (sterile interface cable) and the issue was resolved.The procedure continued.Additional information was received on 20-may-2026.A signal interference (noise/loss) issue was observed on the intracardiac (ic), body surface (bs), or all ecg (bs + ic) channels on all systems.The ekg became unavailable for the physician to monitor the patient¿s heart rhythm.The catheter was in the patient¿s body.The "current leak" alert event was originally considered non-reportable, however, bwi became aware on 20-may-2026 of a signal interference (noise/loss) issue observed on the ic, bs, or all ecg (bs + ic) channels on all systems and the ekg became unavailable for the physician to monitor the patient¿s heart rhythm and have assessed this signal interference issue as reportable.The awareness date for this record is 20-may-2026.

• Brand Name: STERILE INTERFACE CABLE
• Common Device Name: SEE H11
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FOXCONN BAJA CALIFORNIA; parque industrial el lago; tijuana
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25337203
• Report Number: 2029046-2026-01737
• Device Sequence Number: 18674018
• Product Code: QZI
• UDI-Device Identifier: 10846835010121
• UDI-Public: (01)10846835010121(17)290110(10)F100006011
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P240006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: D133701
• Device Lot Number: F100006011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2026
• 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
• Patient Sex: Unknown