MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Catalog Number D139504

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted late due to a retrospective review of complaints for the qdot micro products.Biosense webster¿s investigation determined that upon approval of qdot in the united states on november 23, 2022, the electronic complaints system was not updated and therefore medical device reports were not submitted in a timely manner.Through biosense webster¿s investigation it was determined that this was an isolated case.An internal action was opened to address this issue.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.However, the bwi product analysis lab received a photo of the complaint device.Device investigation details (photo): a picture was received for evaluation following biosense webster's procedures.According to photographic evidence provided by the customer, the photo does not provided sufficient information related to the issue reported by the customer, and therefore no results can be obtained from it.The customer complaint was not confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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 a underwent afib ¿ paroxysmal cardiac ablation ablation procedure with a qdot-micro, bi-directional, f-j curve, c3, split handle catheter.The patient suffered an esophageal ulcer.It was reported esophageal injuries post-op occurred.The physician declared : ¿didn¿t erase a correlation between radiofrequency (rf) delivery modality and complication.The esophageal lesions seems to be related to the mid ablations in the posterior wall of the left atrium.The lesions are completely recovered.¿ patient experienced an adverse event but did not require revision surgery or hardware removal.Medical intervention was gastroscopy and correlated therapy.Patient consequence was esophageal lesions.The event was discovered post use of biosense webster products, the day after the procedure.The physician¿s opinion on the cause of this adverse event is procedure related with noted comment ¿ablation scheme, tissue thickness dependent.Patient condition is good.Outcome is fully recovered (no residual effects) after approximately 3 wee.Ks with new gastroscopy exam.Patient required extended hospitalization to monitor the patient condition after the esophageal lesion.Additionally, reporter confirms a fistula did not occur as there wasn¿t a perforation.Generator was ngen and parameters were qmode + in temperature control mode.Temperature cutoff 65 c, power 90 w.No error messages observed on biosense webster equipment during the procedure.The esophageal injury confirmed the day after the procedure for an esophageal pain.Correct catheter settings were selected on the generator and pump switching from ¿low¿ to ¿high¿ flow during ablation.Carto® 3 system did not indicate to re-zero the catheter.Force visualization features used were graph.Visitag not applicable.Color options used were fti -> light blue, impedence -> green, force -> blue, time -> white, power -> yellow, and temperature -> red.Serial number of the ngen generator: (b)(6).The bwi representative followed up on with physician and reported that patient was very sick, requiring unusual ablation of posterier (pst) wall.Physician admitted to have extensively ablated in pst wall, and confirmed that the over ablation caused the lesion.However, the physician thinks that such kind of ablation scheme would have caused lesions with any type of catheter and it could have been even worst with legacy catheters.No esophageal probe has been used and ppi is administered as per standard practice , if pst box is performed.Patient reported dysphagia so was immediately referred for endoscopy and treated with drugs.He recovered from lesion at follow-up endoscopy.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, F-J CURVE, C3, SPLIT HANDLE CATHETER
• Type of Device: 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: 17615564
• MDR Text Key: 321874298
• Report Number: 2029046-2023-01861
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016741
• UDI-Public: 10846835016741
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D139504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; NGEN PUMP.; NGEN RF GENERATOR.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male