MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30590697m 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).

Event Description

It was reported that a female patient, born on (b)(6), underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a decanav electrophysiology catheter and suffered st elevations, coronary artery dissection with surgical intervention.It was reported that the patient suffered a dissection in the left coronary artery.When the physician tried to prolapse the decanav catheter across the aortic valve into the left ventricle, the physician thought that the catheter momentarily went into the coronary artery instead.There were st changes that clued the physician to check the arteries with dye and fluoroscopy.That was when the dissection was discovered, and the cardiovascular surgeon on call was contacted.No intervention was performed in the lab.The patient was stable and was taken to the cardiovascular operating room (cvor) to repair the dissection.The patient was hemodynamically stable at the time of the report.The dissection was discovered by flouroscopy.The procedure was abandoned.This adverse event was discovered post use of biosense webster inc.(bwi) products.Patient outcome of the adverse event was reported as: ¿my understanding is the patient had a successful operation in the cvor.Details beyond this are not available¿.The patient required extended hospitalization because of the adverse event.Max wattage used: 38 watts, total lesions: 1 lesion in the noncoronary cusp, total ablation time: 48 seconds & total fluid: 248 ml.The physician¿s opinion on the cause of this adverse event is that it may be due to the patient¿s pre-existing condition and that it may also be procedure related.It was reported that: ¿the procedure taking us to the ascending aorta and near the lca¿.

Manufacturer Narrative

Additional information was received on 02-may-2022 and it was reported that the correct product is not available and that it must have been discarded.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: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 12492872
• MDR Text Key: 274450944
• Report Number: 2029046-2021-01580
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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 Expiration Date: 06/28/2022
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 30590697M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 05/02/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2021
• 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: SMARTABLATE GENERATOR KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female