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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Perforation (2513)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional 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 30424486m number, and no internal action 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 or Problem Description
It was reported that a patient underwent surgery for cardiac resynchronization therapy pacemaker (crt-p) implantation on which a webster cs catheter with auto id technology was used and the patient suffered perforation in the coronary sinus (cs) requiring no intervention.During the preparation for the procedure to place the left ventricular lead in the cs, a webster cs catheter with auto id technology was placed in the cs.No changes to the patient¿s blood pressure nor pericardial effusion were noted on echocardiography.The physician then placed the crt-p but a perforation in the cs was confirmed.The device was removed from the patient and was discarded.The patient is scheduled to be implanted with an implantable cardioverter-defibrillator (icd).The remainder of the procedure was discontinued.No medical/surgical intervention was provided.Prolonged hospitalization was not required.The physician is unsure on what device caused the perforation.No biosense webster inc.(bwi) product malfunctions were reported.With the information available, given that the webster cs catheter with auto id technology was placed in the coronary sinus and the physician is unsure on what product caused the perforation, this event is being conservatively reported under the bwi catheter.
Additional Manufacturer Narrative
Additional information was received on (b)(6)2021.It was reported that the patient is a 68-year-old female.Therefore, a2.Patient age at the time of event ¿ 68, a2.Age unit ¿ years, a 3.Gender ¿ female were populated on this report.It was also reported that the implantation of crt-d was stopped and changed to the implantation of icd.The outcome of the adverse event was reported as having no residual effects.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: 11726368
• Report Number: 2029046-2021-00662
• Device Sequence Number: 17031787
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2021

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: 08/20/2023
• Device Model Number: D135303
• Device Catalogue Number: D135303
• Device Lot Number: 30424486M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021; 06/01/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/29/2021; 06/24/2021
• 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: Life Threatening
• Patient Age: 68 YR