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

Catalog Number	301803M
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a preface and while setting up for the procedure, it was noticed that the two product boxes for the preface sheaths were damaged.It appeared as if the "boxes had been left out in the rain," as water had seeped through the box and into the product packaging.There was water inside the inner bag and the inner material was soaked.It was also reported that the pouch seal was damaged in both of the product packages for the preface sheaths, compromising the sterility.The procedure continued utilizing a different preface sheath.
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 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 an atrial fibrillation (afib) ablation procedure with a preface and while setting up for the procedure, it was noticed that the two product boxes for the preface sheaths were damaged.It appeared as if the "boxes had been left out in the rain," as water had seeped through the box and into the product packaging.There was water inside the inner bag and the inner material was soaked.It was also reported that the pouch seal was damaged in both of the product packages for the preface sheaths, compromising the sterility.The procedure continued utilizing a different preface sheath.Device investigation details: the product was returned to johnson & johnson medtech for evaluation.It was sent to the device manufacturer for further investigation.Visual and dimensional analysis of the returned device were performed following johnson & johnson medtech procedures.Visual inspection of the device revealed kinks in the sheath shaft.Additionally, the vessel dilator exhibited kinks.Neither the outer box, nor the pouch were returned for analysis.The guidewire was withdrawn from the dispenser tube and no damage was observed.A dimensional inspection was performed, and measurements taken near the damaged area.They were found to be within specifications.A device history record evaluation was performed for the finished device number 18407082 and no internal actions related to the complaint were found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.The complaint reported by the customer could not be confirmed as the packaging was not returned for analysis.Therefore, the potential cause cannot be determined.The potential cause of the kinks in the dilator and sheath could be related to the shipping/handling after the procedure; however, this cannot be conclusively determined.The kinks in the sheath and dilator issues are unrelated to the reported event.Neither the product history record (phr) review nor the product analysis suggests that the event reported by the customer could be related to the manufacturing process of the unit.H 6.Investigation conclusions code of ¿appropriate term/code not available (d17)¿ refers to unable to analyze due to product returned condition.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22049151
• Report Number: 2029046-2025-01626
• Device Sequence Number: 18407366
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: (01)10846835000047(17)271231(10)18407082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2025

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 Catalogue Number: 301803M
• Device Lot Number: 18407082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 07/08/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 06/13/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: PREF.GUIDING SHEATH W/MULT.CRV.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown