MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134801, PMA # P030031/S078

Catalog Number D139505

Device Problems Material Puncture/Hole (1504); High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection, generator test, and carto 3 test the returned device.Visual analysis of the returned catheter revealed reddish material inside the pebax and a hole on the surface of the qdot micro.Visual inspection was performed, in accordance with bwi procedures.It was found a hole at the pebax with reddish material inside it.Generator testing was performed, in accordance with bwi procedures.The catheter was working correctly, and no impedance issues were detected during the analysis.Carto 3 testing was performed, in accordance with bwi procedures.The catheter was working correctly, and no force issues were detected during the analysis.However, the hole at the pebax with reddish material inside it could be related to the force issue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.It should be noted that product failure is multifactorial.The instruction for use contains the following warnings and precautions: do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.Note: the ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch® sf bi-directional navigation catheter approved under p030031/s078.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

A patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax during product analysis.It was initially reported by the customer that after about 20 minutes since device was inserted the into the cardiac cavity, contact force (cf) value abnormality occurred.Abnormal high cf value was displayed on the monitor, cable was changed and zeroing was reconducted but the issue continued.The qdot-micro, bi-directional, d-f curve, c3, split handle was changed.When this qdot-micro, bi-directional, d-f curve, c3, split handle was removed from the patient¿s body, the pebax portion was contaminated with blood.The catheter was changed and after that, procedure was ended without problem.After the catheter was changed, there was ablation with a gradual impedance rise during ablation, as thrombus was suspected to have adhered, the catheter was removed from the body, and the condition of the tip was visually checked, but there were no abnormalities, and the procedure was continued.The procedure was completed without patient's consequence.Additional information was received which indicated the ablation never continued beyond the cut-off value.Temperature: 52¿, power: 45-35w, impedance: 250o.It was confirmed the pebax was not physically damaged.

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134801, PMA # P030031/S078
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12858609
• MDR Text Key: 285947475
• Report Number: 2029046-2021-02021
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2021
• Device Catalogue Number: D139505
• Device Lot Number: 30446697L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: QDOT MICRO, BI, TC, D-F