MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number BNI75TCDFH

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

Patient Problem Cardiac Tamponade (2226)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30311321m number, and no internal actions 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 patient underwent a premature ventricular contraction (pvc) ablation procedure with an ez steer¿ thermocool® nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure cardiac tamponade was confirmed.Pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.Patient was reported in stable condition after pericardial drainage.It is unknown if extended hospitalization was required.The physician believes the perforation occurred with the ablation catheter.Three electrode catheters, an ablation catheter, a coronary sinus (cs) catheter, and a right ventricle (rv) catheter were used, and only the ablation catheter was used in the left atrium (la) by the transaortic approach.No bwi product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this event is life threatening and required surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2020, bwi received additional information that the patient was a 64-year-old male (74 kg).There is no evidence of steam pop.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: EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10687591
• MDR Text Key: 211884739
• Report Number: 2029046-2020-01487
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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: 11/24/2022
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30311321M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RV CATHETER; UNSPECIFIED CS CATHETER; UNSPECIFIED ELECTRODE CATHETER; UNSPECIFIED ELECTRODE CATHETER; UNSPECIFIED ELECTRODE CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74