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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ischemia Stroke (4418)

Event Date 10/05/2021

Event Type  Injury  

Event Description

Initially the event was reported under the thermocool® smart touch® sf bi-directional navigation catheter/catalog #: d134804 (manufacturer report number: 2029046-2021-01838) and the second concomitant catheter was reported as a "unknown brand catheter".Additional information was received on 02-nov-2021, updated the second concomitant catheter to a ¿thermocool® smart touch® sf bi-directional navigation catheter/catalog #: d134805 ¿.The adverse event for this complaint has also been assessed as mdr reportable under this second bwi ablation catheter.The awareness date for the adverse event under this catheter is 02-nov-2021.It was reported that a (b)(6) male patient underwent an atrial fibrillation (afib) ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheters.The patient suffered a cva.It was also reported that there was foreign material on the usable length of the catheter.After pulmonary vein isolation (pvi), box was conducted.After when left pulmonary vein (lpv) anterior wall ablated and after ablation was started, impedance rose 10~30ohm.Although several points were ablated, same state so the catheter was removed and when checked, thrombus was attached.Therefore, although the catheter flush was performed, the irrigation could not be confirmed from the whole body (there was a possibility of obstruction), the thermocool® smart touch® sf bi-directional navigation catheter was replaced and the procedure was terminated.Char/thrombus additional information: the char /coagulum/thrombus/clot was located at the tip electrode.The system did not present any error messages.Both pvi were conducted.After that, ablation was conducted for roof and bottom, posterior wall isolation was conducted.After the voltage map of la was obtained by prn, the anterior wall of prv and the area around the septum where cfae electrical potentials could be obtained were ablated.Since the impedance increased by about 20 ohms after starting ablation, ablation stopped in about 3 seconds.Although the ablation was performed again after shifting the place, the impedance increased by about 30 ohm just after ablation, and ablation was stopped.Ablation was performed again by changing the place, but the catheter was removed from the cardiac cavity because the impedance increased by about 20 ohm.The catheter tip was confirmed to have a thrombus.After wiping the thrombus with gauze and performing flushing, a catheter was inserted into the cardiac cavity and ablation was performed around the anterior wall and septum of the right pulmonary vein (rpv) again.As the impedance increased by about 3 ohm, the catheter was replaced.After the catheter exchange, no significant increase in impedance was observed, and the following areas were ablated on the line, where were rpv anteroseptal septum, bottom of back wall along coronary sinus (cs) and near laa and the procedure was completed.It seems that cerebral infarction occurred although the details were not told.The prognosis did not seem to be good.Investigator's judgment on the health injury was serious and related to product.Additional information 19-oct-2021: on 08-oct-2021, the verification work was carried out under the leadership of the hospital doctors, ce, and the marketing department.As a result, it was confirmed that there was a partial clogging in the irrigation hole and that the irrigation did not flow uniformly.The physician pointed out that the procedure might have been blocked from before the onset of the event.The patient seemed to have started rehabilitation.The adverse event was discovered post use of biosense webster products.The physician commented that thrombus adhered due to clogging of irrigation hole.Patient outcome of the adverse event was improved.Additional information 21-oct-2021: catheter¿s visual found something white inside the irrigation hole.Requesting to analyze what this material is and analyze any other material confirmed inside or near the tip.Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, was to be considered serious and mdr-reportable.The adverse event was assessed as mdr reportable under both the thermocool® smart touch® sf bi-directional navigation catheters.The following were assessed under the thermocool® smart touch® sf bi-directional navigation catheter/catalog #: d134804: the foreign material on the usable length of the catheter was assessed as mdr reportable.The occlusion/no irrigation issue was assessed as not mdr reportable.Occlusion or no irrigation was highly detectable by the physician.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The char issue was assessed as not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The high impedance cut off exceeded (ablation stopped) 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.

Manufacturer Narrative

Biosense webster manufacturer's reference (b)(4) has (b)(4) complaints that are related to the same incident.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Manufacturer Narrative

Additional information was received on 05-dec-2021.There is no issue reported about the second ablation catheter.The product was used at the procedure during the issue occurred.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 investigation was completed on 31-jan-2022.Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30564261l number, and no internal action related to the complaint was found during the review.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: 12866092
• MDR Text Key: 285933145
• Report Number: 2029046-2021-02040
• 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,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30564261L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2021
• 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: THMCL SMTCH SF BID, TC, F-J
• Patient Outcome(s): Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male