MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NGEN RF GENERATOR, WORLD WIDE CONFIGURATION; SIMILAR DEVICE D134801, PMA # P030031/S078

Catalog Number D138401

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Air Embolism (1697); Fistula (1862); Cardiac Tamponade (2226)

Event Date 06/14/2022

Event Type  Death  

Event Description

It was reported that a male patient born (b)(6) 1980 underwent an atrial fibrillation (afib) ablation procedure with an ngen rf generator, world wide configuration.The patient suffered an esophageal fistula requiring prolonged hospitalization (anesthetized / ventilated and monitored), cardiac tamponade and surgical intervention.Following a bwi representatives visit and meeting with a doctor at (b)(6) hospital, the doctor updated the bwi representatives on an incident of a fistula in one of his patients who had been treated in afib hpsd ablation procedure about two weeks prior.The patient was anesthetized / ventilated and monitored by hospital med team at the time.There was no post-op device malfunction.Additional information was later received indicating the physician stated he conducted a procedure with qmode+, all seemed fine.Temperature and impedances seemed fine, nothing extreme.He does not believe this was a catheter or carto 3 system issue.The patient went home then 2 weeks later he came with pain in the chest.A week later he was diagnosed with fistula and is in severe condition.The physician also mentioned the patient was drinking and using hardcore drugs throughout the process.The physician¿s opinion on the cause of this adverse event is that it was procedure related.The patient required esophagus cover stent implantation and open heart surgery for fixing left atrium (la) tamponade as intervention.The patient condition worsened and the patient was still hospitalized.The ngen rf generator¿s parameters were 90w, 4 sec, qmode+.No error messages were observed on biosense webster equipment during the procedure.The esophageal injury was confirmed by symptoms and an magnetic resonance imaging (mri).The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.The carto® 3 system did not indicate to re-zero the catheter.Qmode+ was used for the case.Additional information received also indicated open heart surgery was performed for the cardiac tamponade.A transseptal puncture was performed with a brk-1 xs series -st.Jude medical (sjm).There was no evidence of steam pop.The irrigation flow setting were set to qdot micro catheter flow setting as recommended.

Manufacturer Narrative

Device investigation details: multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Therefore, no product investigation can be performed, and the customer complaint cannot be confirmed.Since no serial number was provided, no manufacturer record evaluation could be performed.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note: per fda request, mdr submissions for the ngen rf generator are to be reported with pma details of the catheter used along with the ngen rf generator.However, the catheter used in this case, is not fda approved, therefore no pma details are available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).On 13-jul-2022, it was discovered the e.Initial reporters name and contact details were inadvertently omitted from section e.Initial reporter of the 3500a initial medwatch report.As such, the appropriate fields have now been updated.Field e1.Initial reporter phone: (b)(6).Field e2.Health professional? was reported as no but it should have been yes.This has now been corrected.Field g2.Is report source health professional was not checked marked.It has now been check marked.

Manufacturer Narrative

On (b)(6) 2022, biosene webster received additional information was received indicating the patient has died.Reason of death is air embolism.On 18-aug-2022, additional information was received indicating the air embolism was not intra-op.The air embolism was post-op and could be related to reported esophageal fistula.Based on the available information the new addition information of the death related to air embolism will be considered likely related to the esophageal fistula.There has been no previous information provided related intra-procedure air embolism.Therefore, the air embolism will be considered to have occurred post procedure via the esophageal fistula.Additional information has been requested, should more information become available, it will be reviewed and processed accordingly.Note: the date of death is unknown, as such, the date of (b)(6) 2022 has been defaulted into field b2.Date of death as a best estimated date.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 11-aug-2022, it was noticed the incorrect common device name of ¿similar device d134801, pma # p030031/s078¿ was reported under field d2a of the 3500a initial medwatch report.The corrected information is ¿catheter, electrode recording¿ and the field has been updated appropriately.

Manufacturer Narrative

On 19-sep-2022, additional information received indicated the doctor did not specify the exact date of death, it was beginning of august.Additionally, the serial number of (b)(6) was received for the ngen rf generator, world wide configuration.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a male patient born (b)(6) 1980 underwent an atrial fibrillation (afib) ablation procedure with an ngen rf generator, world wide configuration.The patient suffered an esophageal fistula requiring prolonged hospitalization (anesthetized / ventilated and monitored), cardiac tamponade and surgical intervention.On16-aug-2022, biosene webster received additional information was received indicating the patient has died.Reason of death is air embolism.Device evaluation details: the device investigation has been completed which included a device history record (dhr) review.The dhr review that was performed for the finished device number, (b)(6), identified no internal action related to the reported complaint condition.Service for the unit was declined by the customer.As such, the reported complaint cannot be confirmed.No further information could be obtained.A was performed for the finished device number, and no internal action related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.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: NGEN RF GENERATOR, WORLD WIDE CONFIGURATION
• 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): FLEX; hamatechet 2; migdal haemek ; IS
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15008502
• MDR Text Key: 295861101
• Report Number: 2029046-2022-01590
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D138401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/13/2022; 08/11/2022; 08/16/2022; 09/19/2022; 10/27/2022
• Supplement Dates FDA Received: 07/13/2022; 08/11/2022; 09/09/2022; 10/14/2022; 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; QDOT MICRO, BI, TC, D-F.; ST. JUDE MEDICAL BRK-1 XS SERIES NEEDLE.
• Patient Outcome(s): Life Threatening; Required Intervention; Death; Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male