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 Insufficient Cooling (1130); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Manufacturer Narrative

Event year reported was 2021.Photo/video analysis.The bwi product analysis lab received the device for evaluation on 06-jul-2021.The investigation summary was completed on 19-aug-2021.An analysis was performed on the pictures that were provided by the customer.According to the pictures, reddish material was observed in the tip.High temperature evidence was not received.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and temperature evaluation of the device.Visual analysis of the returned catheter revealed reddish material inside the pebax and a hole on the surface of the pebax on the qdot catheter.Generator testing was performed, in accordance with bwi procedures.Further examination revealed that the thermocouple wires were broken from the cut to the tip creating the temperature issue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwis quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: if the radio frequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.If temperature still is not displayed, there may be a malfunction in the temperature sensing system that must be corrected prior to applying rf power.On other hand, regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and the biosense webster, inc.Product analysis lab observed a hole at the pebax.Initially it was reported that there was strange behavior of the temperature in the first ablation points with 50w with qdot-micro, bi-directional, d-f curve, c3, split handle.It was changing from normal temperature below 37¿c to high temperature, above 43¿c, in a rapid manner.The physician took the qdot-micro, bi-directional, d-f curve, c3, split handle outside the patient and blood could been seen into the tip of the catheter, but no charring.The catheter, cable and dongle were changed.The procedure was continued and at the end, the new catheter did not have neither blood nor charring.During the procedure, they had abnormal temperature rise and power decrease but not like the first ablation points as at the beginning.The radio frequency generator settings were : q-mode controlled; minimum impedance: 50ohms; maximum impedance: 250ohms; maximum impedance delta: 100ohms; target temperature: 45¿c; cut-off temperature: 50¿c; maximum low flow temperature: 40¿c; power: 35 or 50w.There was no patient consequence reported.No obvious physical damage of the pebax was observed when looking at the catheter tip.However, caller said can not confirm this information since it is possible that there was some damage that could not be seen.It was not known if there was difficulty maneuvering the catheter or during the withdrawal.The physician did not have any particular comment about the maneuver of the catheter not feeling normal.The cut-off was not exceeded.They system was decreasing the power and increasing the irrigation flow, but ablation was not stopped.The temperature did not go above 50¿c.The high temperature issue was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The foreign material (blood) in the pebax with no external damage was assessed as not mdr reportable.Foreign material was found underneath the pebax.However, there is no damage to the pebax integrity.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 19-aug-2021 there was a hole at the pebax and reddish material inside it.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 19-aug-2021.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12457269
• MDR Text Key: 274767096
• Report Number: 2029046-2021-01518
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2021

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: 09/08/2021
• Device Catalogue Number: D139505
• Device Lot Number: 30385317L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• 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