MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; ELECTRODE, PACEMAKER, TEMPORARY

Catalog Number UNK_WEBSTER CS WITH AUTO ID

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

Patient Problem Cardiac Tamponade (2226)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The manufacturing record evaluation could not be conducted because no lot number was provided by the customer.Biosense webster manufacturer's reference number (b)(4) has three reports related to the same event: mfr # 2029046-2019-03695 for the soundstar eco 8fg ultrasound catheter, mfr # 2029046-2019-03696 for the webster cs catheter with auto id technology, mfr # 2029046-2019-03697 for the webster¿ electrophysiology catheter with auto id (quadripolar).

Event Description

It was reported that a male ((b)(6) kg) patient underwent an atrial fibrillation (af) with a soundstar eco 8fg ultrasound catheter, a webster cs catheter with auto id technology and a webster¿ electrophysiology catheter with auto id and suffered cardiac tamponade requiring pericardiocentesis.During the mapping phase, a pericardial effusion was noticed as the patient's blood pressure dropped before ablating.The soundstar eco 8fg ultrasound catheter, the webster cs catheter with auto id technology and the webster¿ electrophysiology catheter with auto id (quadripolar) were the only catheters in the body.The pericardial effusion was confirmed by echo.Pericardiocentesis was performed to remove around 300cc of fluid.The patient¿s condition reportedly improved as the blood pressure normalized and patient was stable.Physician's opinion is that the effusion was possibly caused by the sheath.The model of the sheath used is unknown.No biosense webster inc.(bwi) product malfunctions were reported.There were no error messages on any bwi equipment.However, since it is not possible to confirm that the effusion was caused by the sheath or one of the 3 bwi catheters, this event will be conservatively reported under all three diagnostic catheters.

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9121721
• MDR Text Key: 165272558
• Report Number: 2029046-2019-03696
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_WEBSTER CS WITH AUTO ID
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 102