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

Catalog Number D139505

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and a rubber-like object was found adhered to the shaft of the qdot micro catheter.Pulmonary vein isolation (pvi) and mi ablation was completed, 2.5 hours after the procedure had started.When additional roof ablation was attempted to be performed and qdot (lot #30985337l) was inserted into the vizigo sheath, the doctor felt abnormal resistance and stopped insertion.The catheter was removed from the body and the shaft was checked, and it was confirmed that a rubber-like object was adhered to the shaft as if wrapped around it.Immediately, the vzigo was also removed from the body, and the inner tube was flushed with a syringe to see if any object remained inside, but no residue was found.The problem was resolved by replacing the qdot micro catheter and vizigo to a new one.There was no patient consequence.The physician's opinions on the relationship between the event and the product was that the substance on the qdot catheter may have been the scraped off material from the rubbery tip of the qdot catheter.

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

The biosense webster, inc.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

The device evaluation was completed on 12-oct-2023.It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and a rubber-like object was found adhered to the shaft of the qdot micro catheter.Pulmonary vein isolation (pvi) and mi ablation was completed, 2.5 hours after the procedure had started.When additional roof ablation was attempted to be performed and qdot (lot #30985337l) was inserted into the vizigo sheath, the doctor felt abnormal resistance and stopped insertion.The catheter was removed from the body and the shaft was checked, and it was confirmed that a rubber-like object was adhered to the shaft as if wrapped around it.Immediately, the vzigo was also removed from the body, and the inner tube was flushed with a syringe to see if any object remained inside, but no residue was found.The problem was resolved by replacing the qdot micro catheter and vizigo to a new one.There was no patient consequence.The physician's opinions on the relationship between the event and the product was that the substance on the qdot catheter may have been the scraped off material from the rubbery tip of the qdot catheter.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, a rubber band-like material can be seen around the shaft in the tip area.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and dimensional test of the returned device were performed following bwi procedures.Visual inspection revealed a whitish foreign material attached around the shaft, close to the tip-shaft transition.A dimensional test was performed, and outer diameters of the device were found within specifications.Due to the foreign material observed, a fourier-transform infrared spectroscopy (ft-ir) analysis was requested, and it was concluded that foreign material is primarily composed of a biological-base material, presumably a tissue residue.A manufacturing record evaluation was performed for the finished device 30985337l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The resistance issue reported could not be replicated during the product analysis.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported resistance with sheath issue.Investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the rubber-like object that was found adhered to the shaft.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: QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE
• 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: 17659151
• MDR Text Key: 322371301
• Report Number: 2029046-2023-01950
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 10846835016758
• UDI-Public: 10846835016758
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D139505
• Device Lot Number: 30985337L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; QDOT MICRO, BI, TC, D-F; UNK_CARTO 3; UNK_QDOT ECO CABLE