MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and a package damage issue occurred.It was reported that the 4mm catheter packaging was a little damaged on the outside.The box seemed crushed and when they opened the box, the catheter inside was crushed and there was a hole in the outer barrier of the catheter.The catheter was never opened from the sterile packaging due to the crushed handle.Another catheter was used to complete the procedure.No adverse patient consequence was reported.
Additional Manufacturer Narrative
The device evaluation was completed on 11-aug-2023.It was reported that a patient underwent a supraventricular tachycardia (svt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and a package damage issue occurred.It was reported that the 4mm catheter packaging was a little damaged on the outside.The box seemed crushed and when they opened the box, the catheter inside was crushed and there was a hole in the outer barrier of the catheter.The catheter was never opened from the sterile packaging due to the crushed handle.Another catheter was used to complete the procedure.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual inspection revealed that the rocker arm and part of the handle of the device were found broken.Additionally, according to the pictures provided by the customer, it was observed that the outer box and pouch have marks of damage that compromised the proper sterilization of the device; however, the package and pouch were not returned for analysis.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint were identified.The device handle issue was confirmed.The damage observed could be related to the handling of the device before the procedure, during the transportation process, and after the device left the facilities; however, this cannot be conclusively determined at this time.The pouch and package were not returned; therefore, these issues cannot be confirmed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.Explanation of codes: investigation findings: fracture problem (c070603 / investigation conclusions: cause not established (d15) / component code: handpiece (g04063) were selected as related to the device handle issue.Investigation findings: fracture problem (c070603 / investigation conclusions: cause not established (d15) / component code: actuator (g04002) were selected as related to the rocker arm and part of the handle of the device that were found broken.Investigation findings: no findings available (c20) / investigation conclusions: appropriate term/code not available (d17) were selected as the pouch and package were not returned and therefore, unable to analyze this issue further.Investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause traced to transport/storage (d04) / component codes: packaging (g04094) and handpiece (g04063) were selected as related to the photo analysis.Investigation findings: packaging problem identified (c1605) and packaging compromised (c160501)/ investigation conclusions: cause traced to transport/storage (d04) / component codes: packaging (g04094) was selected as related to package and pouch damage.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: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17484848
• Report Number: 2029046-2023-01722
• Device Sequence Number: 15424083
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 05/12/2026
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31053641M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2023
• 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
• Patient Sex: Unknown