MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	10439236
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 27-feb-2025, 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.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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar and a hole in sterile packaging was found.It was reported by the caller that when preparing to open the catheter, it was noticed there was a pin hole in the packaging.The caller saw the hole while removing the catheter from the box.The hole goes through both levels of sterile packaging.The caller replaced the catheter to resolve the issue.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar and a hole in sterile packaging was found.It was reported by the caller that when preparing to open the catheter, it was noticed there was a pin hole in the packaging.The caller saw the hole while removing the catheter from the box.The hole goes through both levels of sterile packaging.The caller replaced the catheter to resolve the issue.There was no patient consequence.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection was performed.The device was received without external packaging; only the opened pouch with the device was received.Visual inspection revealed that the pouch had a puncture/perforation at the top, which matches with the pictures provided by the customer.A device history record evaluation was performed for the finished device number, and no internal action related to the reported condition were identified.The packaging issue reported by the customer was confirmed.The potential cause may be attributed to device shipping/handling.However, this cannot be determined with the information available.The failure may have occurred outside of j&j medtech controls.The instructions for use (ifu) states: "do not use the soundstar® catheter if the packaging is open or damaged." as part of johnson & johnson medtech'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: SOUNDSTAR
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): SIEMENS LTD. SEOUL; venture bldg 2, office 112 601; pohang technopark, jigok-dong; gyeongbuk 790-8 34; KS 790-834
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21521432
• Report Number: 2029046-2025-00666
• Device Sequence Number: 18537880
• Product Code: OBJ
• UDI-Device Identifier: 10846835008869
• UDI-Public: (01)10846835008869(17)251203(10)G9442416
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140318
• 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

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: 12/03/2025
• Device Catalogue Number: 10439236
• Device Lot Number: G9442416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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: CARTO 3 SYSTEM; NGEN RF GENERATOR; SOUNDSTAR ECO GE 8F CATHETER
• Patient Sex: Unknown