MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	D708DR002RT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a webster¿ electrophysiology catheter and the catheter kinked resulting in a breakage which exposed internal wiring.It was reported that upon advancing the webster¿ electrophysiology catheter, it did not advance correctly into the zone on the carto 3 system.When the catheter was removed from the body they noticed the catheter loop had kinked and the insulation was broken.The damage was not noticed before the catheter being inserted into the body.The catheter was replaced using the same sheath to resolve the issue.Additional information was received indicating the insulation was broken, and there appeared to be exposed wires.The damage did not result in any lifted or sharp rings.The catheter prolapsed within the vessel and eventually doubled back superiorly.The catheter was not pre-shaped, the physician attempted to advance the catheter the same as she always does but there was difficulty during insertion.The sheath used was a fastcath 7f short sheath (non-bwi).
Additional Manufacturer Narrative
On (b)(6)2022, the bwi product analysis lab received the complaint device for evaluation.The product 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.Manufacturer's ref.#(b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a webster¿ electrophysiology catheter and the catheter kinked resulting in a breakage which exposed internal wiring.It was reported that upon advancing the webster¿ electrophysiology catheter, it did not advance correctly into the zone on the carto 3 system.When the catheter was removed from the body they noticed the catheter loop had kinked and the insulation was broken.The damage was not noticed before the catheter being inserted into the body.The catheter was replaced using the same sheath to resolve the issue.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi then conducted visual inspection of the returned webster¿ electrophysiology catheter.Visual analysis of the returned sample revealed the shaft was kinked at 44in from the handle area.No internal parts were exposed.The root cause of the shaft bent cannot be determined, it could be related to the handling of the device, however, this cannot be conclusively determined.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process to avoid this type of damage from leaving the facility.In addition, the customer also provided pictures of the complaint device to aid in the investigation.According to pictures provided by customer, the shaft appears to be bent, however, picture quality does not allow to determine if there are internal parts exposed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.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¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13237884
• Report Number: 2029046-2022-00084
• Device Sequence Number: 17325238
• Product Code: DRF
• UDI-Device Identifier: 10846835000269
• UDI-Public: 10846835000269
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K892265
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2024
• Device Model Number: D708DR002RT
• Device Catalogue Number: D708DR002RT
• Device Lot Number: 30650002M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 02/07/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 01/18/2022; 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEF 7F 8P,D,SD,115CM,R10; FASTCATH 7F SHEATH
• Patient Sex: Unknown