MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10439011
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter and an open pouch seal occurred.It was reported the package was damaged and torn.There was no crushed box, only a hole in the inside packaging.The issue was identified before the procedure, during preparation.There was no damage to the deviceas it was secured properly in the tray.The issue was resolved by replacing the soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter to another new one and the procedure was completed without patient's consequence.
Additional Manufacturer Narrative
The product has not returned for analysis, however, a pictures were provided by the customer.Evaluation is still in progress.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.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.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the returned device found witness marks that suggest there was the intent of implantation of the sigma hp uni ins sz3 9mm lm/rl however, there is no significant damage that could compromise the functionality of the device.Additionally, the mating component remains unknown and was not returned for investigation.The reported allegation cannot be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4); 2) date of manufacture: 03/26/2021; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 02/28/2023; 5) ifu reference: 103085738 rev 2.Device history review: 1) quantity manufactured: (b)(4); 2) date of manufacture: 03/26/2021; 3) any anomalies or deviations identified in dhr: none; 4) expiry date: 02/28/2023; 5) ifu reference: 103085738 rev 2.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 22-sep-2023, the h6.Investigation conclusions code was corrected from appropriate term/code not available (d17) to cause not established (d15) as it was reported incorrectly in the 3500a supplemental mdr follow up 2.
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter and an open pouch seal occurred.It was reported the package was damaged and torn.There was no crushed box, only a hole in the inside packaging.The issue was identified before the procedure, during preparation.There was no damage to the device as it was secured properly in the tray.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation.Bwi conducted a visual inspection evaluation of the returned device.The evaluation has been completed.Visual analysis revealed no damages or anomalies on the device.The packaging was not returned for analysis, due to this condition the issue reported by the customer was not possible to be confirmed.According to the picture provided by the customer, the sterilization package was open, compromising the sterility of the catheter.The customer complaint could only be confirmed based on the picture received, but not from the returned device.A device history record evaluation was performed and no internal actons related to the complaint were found during the review.As part of the 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 ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
• 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: 17275683
• Report Number: 2029046-2023-01457
• Device Sequence Number: 19724511
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 05/09/2024
• Device Model Number: 10439011
• Device Catalogue Number: 10439011
• Device Lot Number: E8463615
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 08/15/2023; 09/22/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/24/2023; 09/07/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOUNDSTAR ECO SMS 8F CATHETER.
• Patient Sex: Unknown