MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D135303
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with a webster cs catheter with auto id technology where device entrapment occurred.It was reported that the webster cs catheter with auto id technology became entrapped in the patient's coronary sinus osteum and could not be easily removed.The cardiothoracic surgeon was speaking to the patient at the time of the call and that they will likely be sent to surgery for removal.The patient was stable, and no injury was reported at the time of the call.There is no information about the hospitalization.The reported device entrapment was assessed as a mdr reportable malfunction.Although there¿s no confirmation that surgical intervention was performed, with the information available, it is most likely that the patient had to undergo surgery to have the catheter removed from its body; therefore, surgical intervention was assessed as a patient consequence.Since surgical intervention was required to prevent permanent impairment of a body function or permanent damage of a body structure, then the event was to be considered serious and mdr-reportable.
Additional Manufacturer Narrative
Additional information was received on the event on (b)(6) 2021.It was reported that the webster cs catheter with auto id technology became entrapped in the patient's coronary sinus osteum and could not be easily removed.Remainder of the procedure was aborted.The patient was sent to the operating room (or) to surgically remove the device.Prolonged hospitalization was not required.Patient had fully recovered.Physician believes the issue occurred due to a product malfunction.In addition, the physician contact information was provided; therefore, e1.Initial reporter title; e1.Initial reporter first name; e1.Initial reporter last name; e1.Initial reporter email; e2.Health professional; and e3.Initial reporter occupation were populated.The bwi product analysis lab received the device for evaluation on (b)(6) 2021.The device evaluation was completed on (b)(6) 2021.It was reported that a patient underwent cardiac ablation procedure for paroxysmal atrial fibrillation with a webster cs catheter with auto id technology where device entrapment occurred requiring surgical intervention.The device was visually inspected and it was found in good conditions.No damages were found on electrodes or tip.The catheter passed the outer diameter test.The magnetic, features were tested, and no issues were observed.In addition, the catheter was deflecting correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30450191m number, and no internal action was found during the review.The catheter passed all specifications.The root cause of the adverse event remains unknown.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: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11166218
• Report Number: 2029046-2021-00053
• Device Sequence Number: 11631005
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: D135303
• Device Catalogue Number: D135303
• Device Lot Number: 30450191M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention