MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT MICRO; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number	D139505
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a non-ischemic ventricular tachycardia (isvt) procedure with a qdot micro for which biosense webster¿s product analysis lab (pal) identified a separation between the pebax and electrode section.It was reported by the customer that there was a catheter replacement due to the system test using a qdot micro.It was reported that when coming on radio frequency (rf) with the qdot micro catheter, the force value climbs to 90 grams on the carto 3 system, though no errors were present.The extension cable and catheter were exchanged without resolution.The patient has an implantable cardioverter defibrillator (icd).The caller was advised to exchange the tx eco cable, then error 202: temperature distribution display is disabled, appeared on the carto and error 170: electrode- temperature fault, appeared on the ngen.The connection "didn't feel right" when connecting the second tx eco cable to the patient interface unit (piu).They exchanged it again with another spare and the errors resolved.They came on radiofrequency (rf) but the high force issue returned.They exchanged the extension cable again (all reprocessed), and the caller was advised to exchange the console to piu rf cable.Instead, they switched to an smarttouch sf catheter to continue, as the physician did not want to troubleshoot further the qdot issue.The port did not appear damaged upon visual inspection.Caller provided post procedure update.The new qdot dongle did not work.When they plugged the dongle into the piu she received error 170, electrode temperature fault, on the ngen generator.The dongle was replaced and the procedure continued.Requested 2 qdot catheters for replacement.Additional clarification received.During troubleshooting, tested a new ngen extension dongle which upon testing found that the new extension dongle was broken.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 14-jan-2025 foreign material presumably blood inside the pebax.Additionally, under microscope inspection, it was found a separation between the pebax and electrode section.The event was originally considered non-reportable, however, bwi became aware of a separation between the pebax and electrode section on 14-jan-2025 and have assessed this returned condition as reportable.
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection test of the returned device was performed following j&j medtech procedures.Visual inspection revealed foreign material presumably blood inside the pebax.Additionally under microscope inspection, it was found a separation between the pebax and electrode section.It was reported that when coming on rf with the qdot micro catheter, the force value climbs to 90 grams on the carto 3 system, though no errors were present.Prior to calling the extension cable and catheter were exchanged without resolution.Caller stated that the patient has an icd a manufacturing record evaluation was performed for the finished device 31416861l number, and no internal action related to the reported complaint condition were identified.The foreign material and separation between the pebax and electrode were unrelated to the reported event by the customer.The root cause of the pebax damage might be related to a manufacturing process.No more test was required since the customer reported catheter replacement due to a system test.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.An internal corrective action has been opened to address manufacturing opportunities related to the force sensor sleeve insolation to prevent fluids to get inside into the device.Explanation of codes: -investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to manufacturing (d03) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of ¿foreign material presumably blood inside the pebax¿ and ¿separation between the pebax and electrode section¿.-investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿catheter replacement due to system testing¿.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿manufacturing process¿ related.Manufacturer's reference number: (b)(4).

• Brand Name: QDOT MICRO
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21329407
• Report Number: 2029046-2025-00370
• Device Sequence Number: 12600193
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: (01)10846835016758(11)240823(17)270822(10)31416861L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• 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
• Report Date (Section B): 02/06/2025

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: D139505
• Device Lot Number: 31416861L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: CARTO 3 SYSTEM; EXTENSION CABLE; QDOT MICRO, BI, TC, D-F; SMARTTOUCH SF CATHETER; TX ECO CABLE; UNK_NGEN RF GENERATOR
• Patient Sex: Unknown