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

Model Number D134801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30384672m number, and no non-conformances 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 ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® sf bi-directional navigation catheter and suffered complete heart block requiring temporary pacemaker.After right ventricular outflow tract (rvot) mapping, right coronary cusp (rcc) mapping and ablation from below was performed.After ablation for approximately 1 minute at 30 w, clinical pvc disappears but became complete atrioventricular block (cavb).The distance from the place where his was marked on carto to the ablation point was 26.4 mm, and there was no his potential in the ablation catheter immediately before ablation.The event occurred 1.5 hour since the beginning of the catheter use.The right bundle branch block (rbbb) pattern was immediately after the block, but after atropine iv and isoproterenol (isp) was administered, the leg [branch] block was resolved, and the narrow qrs was similar to the qrs when entering the room.Although the physician waited, there was no return to sinus rhythm (sr) and the patient left the room after a temporary pacemaker insertion.The next morning, the status quo is still cavb.Since the rate of replenishment tuning is 50-60bpm, there is no temporary backup.The physician¿s commented that there is no causal relationship.The physician's experience suggests that he can expect to return to sinus rhythm over time, and that he is currently non-serious.The waveform at discharge 3 days after the operation was 2: 1 avb.(rate: 50-60bpm) it is judged that the patient's wishes and the resumption of conduction in the future remote period can be expected, and the pacemaker will not be implanted.

Manufacturer Narrative

On 10/13/2020, biosense webster inc.Received additional information about the patient and event.It was reported the patient was a 71-year-old male.The event occurred during use of biosense webster products.The physician¿s opinion is that the cause of the event was patient¿s condition.The patient was discharged from the catheter room with a temporary pacing catheter inserted.The patient¿s condition has improved and the physician expects that the patient's condition will recover in the late stage.No extended hospital stay required.Correction: it was noticed that the h6.Patient code 3191 (no code available) used to represent ¿surgical intervention¿ was inadvertently omitted from the initial 3500a medwatch report.As such, the code has now been added.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10622172
• MDR Text Key: 209792173
• Report Number: 2029046-2020-01391
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30384672M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO3 EXTERNAL REFPATCH 6PACK
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR