MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE; INTRODUCER, CATHETER

Catalog Number	301805M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a preface and when pulling out the catheter, the physician noticed the seal of the sheath coming out with the catheter.The sealing with the catheter proximal fell off.No patient consequence.Additional information was received on 07-aug-2024.Pulling out the catheter, the physician noticed the seal of the sheath coming out with the catheter.This issue is not related to the catheter touching a non-sterile surface.The catheter was used on the patient.It was used for the procedure and the issue was noticed when pulling out the catheter.This event was originally considered non-reportable, however, bwi became aware of additional information clarifying when ¿pulling out the catheter, the physician noticed the seal of the sheath coming out with the catheter¿ on 07-aug-2024 and have reassessed the event as reportable.The awareness date for this reportable issue is 07-aug-2024.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 08-oct-2024.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 an ablation procedure with a preface.The sealing with the catheter proximal fell off.No patient consequence.Additional information was received.Pulling out the catheter, the physician noticed the seal of the sheath coming out with the catheter.The catheter was used on the patient.It was used for the procedure and the issue was noticed when pulling out the catheter.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 27-dec-2024, observed the brim cap detached from the sheath.The bwi product analysis lab became aware of the brim cap detached from the sheath.On 27-dec-2024 and have also assessed this returned condition as reportable.The device evaluation details: the product was returned to johnson & johnson medtech for evaluation.Visual and microscopical inspections, along with a dimensional test, were conducted following johnson & johnson medtech procedures.Visual analysis revealed the brim cap detached from the sheath; this component was not returned for analysis.No other anomalies were observed.Dimensional analysis was performed without issues, all values were within specifications.The microscopical inspection in the hub component did not revealed damages.A device history record evaluation was performed for the finished device, and no internal actions related to the complaint were found during the review.The hemostatic valve issue reported by the customer was confirmed due to the detached brim cap observed during analysis.However, the potential cause of the detachment could not be determined.The analysis does not suggest that the reported failure is related to the manufacturing process of the unit.As part of johnson & johnson medtech 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 reference number: (b)(4).

• Brand Name: PREFACE
• Common Device Name: INTRODUCER, CATHETER
• 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: 20136124
• Report Number: 2029046-2024-02946
• Device Sequence Number: 7287052
• Product Code: DYB
• UDI-Device Identifier: 10846835000061
• UDI-Public: (01)10846835000061(17)251130(10)18169406
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K982740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

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: 11/30/2025
• Device Catalogue Number: 301805M
• Device Lot Number: 18169406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 12/27/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/21/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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: UNK CATHETER
• Patient Sex: Unknown