MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285); Contamination /Decontamination Problem (2895); Patient Device Interaction Problem (4001)

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

Event Date 12/24/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and observed foreign material inside the pebax with external damage.Initially it was reported that the vector was abnormal and there was a pop feeling and sound at the doctor's hand during ablation.The impedance also dropped by about 20.When we looked at the tip of the catheter, blood was accumulated inside (between the first and second poles).This occurred during right pulmonary vein ablation.The issue was resolved by changing the catheter to another one.Postoperative pericardial effusion was absent.After the operation, the patient returned to the ward as usual.The physician commented that it was unclear whether it was because of the pooling of blood or the pooling of blood at the tip (inside) of the catheter.There was no patient consequence reported.The force issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The low impedance issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Since there was no damage to the pebax integrity reported, the reported ¿blood accumulated inside¿ issue was assessed as not mdr reportable for foreign material found underneath the pebax with no external damage.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on the event on 26-jan-2022.It was not reported that inappropriate use was conducted without instructions for use.Another company's sheath was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was physically damaged.Since the additional information received stated that there was physical damage to the pebax, the pebax issue was re-assessed as mdr reportable for foreign material inside the pebax with external damage.Therefore, the awareness date of this reportable issue is 26-jan-2022.

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 14-feb-2022.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

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.It was reported that the vector was abnormal and there was a pop feeling and sound at the doctor's hand during ablation.The impedance also dropped by about 20.When we looked at the tip of the catheter, blood was accumulated inside (between the first and second poles).This occurred during right pulmonary vein ablation.The issue was resolved by changing the catheter to another one.Postoperative pericardial effusion was absent.After the operation, the patient returned to the ward as usual.The physician commented that it was unclear whether it was because of the pooling of blood or the pooling of blood at the tip (inside) of the catheter.There was no patient consequence reported.Additional information was received on the event.It was not reported that inappropriate use was conducted without instructions for use.Another company's sheath was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.The catheter pebax was physically damaged.The device evaluation was completed on (b)(6) 2022.The device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and functional test of the returned device.Visual analysis of the returned smart touch bidirectional sf catheter revealed reddish material inside the pebax and a hole on the surface.Generator and cool flow pump and pressure gauge test were performed in accordance with bwi procedures.The device was working correctly, and no temperature or irrigation issues were detected during the analysis.Additionally, the impedance was displayed properly on the generator.Magnetic sensor functionality test was performed, in accordance with bwi procedures.The returned sample was connected to carto 3 system and error 105 & 106 was displayed on the screen.Therefore, the catheter was dissected on the tip area, loss of electrical continuity of the paired wires to the sensor was found.Concluding that is an internal failure of the sensor.The wire breakage and the pebax with reddish material could be related to the force issue.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The instructions for use contain the following warning stated in the carto 3 system manual for the force sensor error: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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.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 ¿steam pop¿ and ¿low impedance¿.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code membrane (g04088) were selected as related to the customer¿s reported ¿foreign material inside the pebax - external damage¿.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code sensor (g03012) were selected as related to the customer¿s reported ¿force issue¿.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: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 13563915
• MDR Text Key: 289008010
• Report Number: 2029046-2022-00341
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30637747L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• 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: NON BWI - SHEATH; UNKNOWN BRAND CATHETER