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

Model Number D128211

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

Patient Problem Cardiac Tamponade (2226)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

On 10/9/2020, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report 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).

Event Description

It was reported that a female patient underwent cardiac ablation procedure for atrial fibrillation (afib) with pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that the first transseptal puncture (brk needle with sl1 (abbott)) was done and the pentaray catheter was inserted.The second transseptal puncture was completed and the patient¿s blood pressure dropped.Ultrasound confirmed a pericardial effusion.The physician believed the event was caused by either the first or second transseptal crossing.The adverse event was noticed after the pentaray nav high-density mapping eco catheter had been placed in the left atrial appendage (laa).No ablation cathter was used; no ablations were performed.No other bwi products were being used.The physician¿s opinion is that the cause of this event was procedure.Pericardiocentesis was performed.Pentaray nav high-density mapping eco catheter was under pressure bag.Pericardiocentesis was enough to manage bleeding until it stopped.There is no further information about the hospitalization.According to doctor, patient healed and is now home and doing well.

Manufacturer Narrative

It was reported that a female patient underwent cardiac ablation procedure for atrial fibrillation (afib) with pentaray nav high-density mapping eco catheter and suffered cardiac tamponade requiring surgical intervention.It was reported that the first transseptal puncture (brk needle with sl1 (abbott)) was done and the pentaray catheter was inserted.The second transseptal puncture was completed and the patient¿s blood pressure dropped.Ultrasound confirmed a pericardial effusion.The physician believed the event was caused by either the first or second transseptal crossing.No ablation cathter was used; no ablations were performed.No other bwi products were being used.The physician¿s opinion is that the cause of this event was procedure.Device evaluation details: the device evaluation has been completed.The returned device was visually inspected, and it was found in normal conditions.The magnetic, electrical features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30388214l number, and no internal action was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.The (instruction for use) ifu states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10675935
• MDR Text Key: 211693928
• Report Number: 2029046-2020-01477
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30388214L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK NEEDLE WITH SL1 (ABBOTT); CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-WW
• Patient Outcome(s): Life Threatening; Required Intervention