MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D128207
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered cardiac perforation.After the transseptal puncture the pentaray nav high-density mapping eco catheter was noted to be in the pericardium and a blood effusion (pericardial effusion) was noticed.The procedure was interrupted, and the catheter pulled out of the patient's heart.The procedure was not successfully completed.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event to be procedure related.The patient outcome of the adverse event was reported as improved.A transseptal puncture had been performed with a heart span from biosense webster.Ablation wasn¿t performed, as such, the smartablate generator was not used.It was noticed that they were in the pericardium during the mapping phase.This will be coded as cardiac perforation because the pentaray nav high-density mapping eco catheter was noted to be in the pericardium.There is no mention of pericardiocentesis or surgical intervention.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.However, investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and the patient suffered cardiac perforation.After the transseptal puncture the pentaray nav high-density mapping eco catheter was noted to be in the pericardium and a blood effusion (pericardial effusion) was noticed.The procedure was interrupted, and the catheter pulled out of the patient's heart.The procedure was not successfully completed.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event to be procedure related.The patient outcome of the adverse event was reported as improved.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 30704149l identified no internal actions related to the reported complaint condition.Still no device has been received for analysis, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Based on the completed mre, the h4.Device manufacture date has been populated with 22-dec-2021.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: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14485330
• Report Number: 2029046-2022-01116
• Device Sequence Number: 5322702
• Product Code: MTD
• UDI-Device Identifier: 10846835012217
• UDI-Public: 10846835012217
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2024
• Device Model Number: D128207
• Device Catalogue Number: D128207
• Device Lot Number: 30704149L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71CM TRANSSEPTAL NEEDLE; HEARTSPAN TRANSSEPTAL NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown