MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

Catalog Number UNK_PENTARAY

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

Patient Problem Cardiac Tamponade (2226)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure and suffered cardiac tamponade requiring pericardiocentesis.During the procedure transseptal puncture was performed with a bailys transseptal needle, and a thermocool® smart touch® sf bi-directional navigation catheter was inserted into the patient¿s left atrium (la) but was never used/moved from original position which appeared to be in the middle of the chamber.Fast anatomical mapping (fam) was then done with a pentaray nav high-density mapping catheter.While mapping, the physician noticed a 2cm pericardial effusion by intracardiac echography (ice).The physician paused the procedure and monitored for 5-10 minutes.The effusion grew from 2cm to 6 cm and the physician decided to abort the procedure.Pericardiocentesis was performed and about 200 ml of fluid was removed.There were no hemodynamic changes noted and the patient remained stable.Prolonged hospitalization was not required, the patient stayed overnight only for monitoring.Patient had fully recovered from the event.The physician is unsure about the causality of the event, he believed it occurred during transseptal since a perforation with the pentary catheter would be unlikely.With the information available, this event is being conservatively reported under the pentaray catheter since the event was noticed during its use for mapping; therefore, it cannot be excluded.The event won¿t be reported under the ablation catheter since no ablation was done prior to the adverse event occurrence and the catheter was not manipulated inside the la.Impacted product (ip-01022267) was created with a generic code for pentaray since the catheter information is not available at the time.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

Multiple attempts have been made for device return.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
• Type of Device: PENTARAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10849193
• MDR Text Key: 216561389
• Report Number: 2029046-2020-01751
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_PENTARAY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: BAYLIS TRANSEPTAL NEEDLE; THMCL SMTCH SF BID, TC, F-J; UNK_SOUNDSTAR; UNK_WEBSTER CS WITH AUTO ID; BAYLIS TRANSEPTAL NEEDLE; THMCL SMTCH SF BID, TC, F-J; UNK_SOUNDSTAR; UNK_WEBSTER CS WITH AUTO ID
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR