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

Catalog Number	BD710FJ282CT
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.The 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.A manufacturing record evaluation was performed for the finished device 30166547m number, and no internal actions related to the reported complaint condition were identified.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster ® cs catheter with ez steer® thechnology and auto id catheter and it was reported that there was electrode damage and foreign material on the catheter.Initially, it was reported that there was an issue with deflection and that the catheter wasn't working properly.When removed from the body the catheter was noticed to have an electrode that wasn't complete, the distal tip seemed to have a drop of glue on the electrode, and the electrode did not seem to come all the way to the tip and seemed to be embedded in the plastic.The catheter was replaced, and the issue resolved.There was no patient consequence.The deflection issue was assessed as a not reportable event.The issue of electrode damaged with foreign material was reviewed and assessed a reportable event.The biosense webster, inc.Product analysis lab received the device for evaluation on may 10, 2019 and it was reported that there was no visual damage or anomalies observed.
Additional Manufacturer Narrative
Investigation summary - it was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster ® cs catheter with ez steer® thechnology and auto id catheter.It was reported that there was an issue with deflection and that the catheter wasn't working properly.When removed from the body the catheter was noticed to have an electrode that wasn't complete, the distal tip seemed to have a drop of glue on the electrode, and the electrode did not seem to come all the way to the tip and seemed to be embedded in the plastic.The catheter was replaced, and the issue resolved.There was no patient consequence.The device was visually inspected and it was found in good condition.No electrode damage was observed.Additionally, the part described under the event is the anchor window and is part of the design of the catheter.Then a deflection test was performed, and it was found within specifications.The catheter was deflecting correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.Manufacturer's reference # (b)(4).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8617378
• Report Number: 2029046-2019-03154
• Device Sequence Number: 11317778
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2022
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 30166547M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1