MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number BD710DF282CT

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  malfunction  

Event Description

A patient underwent a cardiac ablation procedure with a webster ® cs catheter with ez steer® technology and auto id for which biosense webster¿s product analysis lab (pal)identified the catheter tip to be broken.It was initially reported by the customer that after opening the catheter it looks like the outer portion is rubbed off/ affected.It was described as the outer blue portion of the catheter looked as if it had been rubbing on something and compromised the outer layer.I did not see any exposed wires.There did not appear to have any sharp edges, however the outer potion of the catheter was shaved down.The catheter was replaced and the issue resolved.There was no patient consequence.The customer reported issue was assessed as not mdr reportable since the issue occurred outside the patient body so the risk to the patient for serious injury is low.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 21-apr-2022, the bwi pal revealed a visual inspection of the returned device found that the tip was rubbed off with internal components exposed.This was assessed as an mdr reportable broken tip issue.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis of the returned device revealed the catheter tip was rubbed off exposing internal components.Additionally, the customer provided picture(s) of the complaint device to help aid in the investigation.According to pictures provided by the customer, the catheter shaft was observed damaged, however, internal parts exposure was not observed in the picture(s).All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.The issue was further investigated by the manufacturing team revealing that the complaint unit passed all controls and inspections successfully according to the device history record.It was also determined that the complaint unit is the only one reported during a 1-year period, and therefore, it's considered an isolated case with multifactorial reasons that might lead to this defect.Based on the information available, it was determined that the damage is not related to manufacturing and occurred after the device left the manufacturing process.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the product investigation of the received sample.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: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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 ; 646591-798
• MDR Report Key: 14438709
• MDR Text Key: 292184542
• Report Number: 2029046-2022-01054
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090898
• 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: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD710DF282CT
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 30701190M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BI DIR 7FR DEF CS,D-F,12 PIN