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

Model Number	D610DRP10RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a webster¿ electrophysiology catheter and a broken tip issue occurred.It was reported that during the procedure, the tip of the catheter was found bent, and wire was exposed.A second catheter was used to complete the operation.There was no patient adverse event reported.
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).
Additional Manufacturer Narrative
The photo analysis was completed on (b)(6)-2022.It was reported that a patient underwent a cardiac ablation procedure with a webster¿ electrophysiology catheter and a broken tip issue occurred.It was reported that during the procedure, the tip of the catheter was found bent, and wire was exposed.A second catheter was used to complete the operation.There was no patient adverse event reported.According to the pictures provided by the customer, the tip was observed bent.A manufacturing record evaluation was performed for the finished device 30584758m number, and no internal actions related to the reported complaint condition were identified.It should be noted that product failure is multifactorial.The instructions for use contain the following: confirm that the thumbknob is pulled back completely before insertion.Advance the catheter to the area of the endocardium under investigation.Use both fluoroscopy and electrograms to aid in proper positioning.Adjust the radius of curvature as necessary by manipulating the thumbknob.Pushing the thumbknob forward causes the catheter tip to bend (curve); when the knob is pulled back, the tip straightens.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Explanation of codes: investigation findings: mechanical problem identified (c07)/ investigation conclusions: cause not established (d15)/ component code: tip (g04129)were selected as related to the bent tip.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a webster¿ electrophysiology catheter and a broken tip issue occurred.It was reported that during the procedure, the tip of the catheter was found bent, and wire was exposed.A second catheter was used to complete the operation.There was no patient adverse event reported.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation.Bwi conducted a visual inspection test of the returned device.Visual analysis of the returned sample revealed that the tip was broken with internal parts exposed.A manufacturing record evaluation was performed for the finished device batch number 30584758m, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This unit was inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) of this device per its part number that indicates proper manufacturing in accordance with documented specifications and procedures.At this time is not possible to determine the root cause of this condition, however, based on the information provided, the condition reported has origin in someplace external to the manufacturing environment.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: 13285960
• Report Number: 2029046-2022-00113
• Device Sequence Number: 4978682
• Product Code: DRF
• UDI-Device Identifier: 10846835000238
• UDI-Public: 10846835000238
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/07/2022

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: 06/14/2024
• Device Model Number: D610DRP10RT
• Device Catalogue Number: D610DRP10RT
• Device Lot Number: 30584758M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 01/03/2022; 02/11/2022; 03/10/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 01/26/2022; 03/08/2022; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• 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: UNKNOWN BRAND CATHETER
• Patient Sex: Unknown