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

Model Number	10439072
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation details: a picture was received for evaluation and was evaluated following biosense webster's procedures.According to picture provided by the customer, white particles were observed on the handle of the soundstar catheter, however, the source of the foreign material remains unknown.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the picture analysis results.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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® eco diagnostic ultrasound catheter and a foreign material was encountered.It was reported that it was discovered after the catheter was removed from the packaging that the catheter was covered in a white flaky substance.The caller stated that the white flaky substance was discovered on the shaft, connector, and handle of the catheter.They replaced the catheter with an acunav catheter and the procedure continued without further issues.There was no patient consequence as it was not placed in body due to substance on catheter.
Additional Manufacturer Narrative
On 28-apr-2023, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed the h6.Type of investigation code of ¿analysis of production records (b14)¿ was inadvertently omitted from the 3500a initial medwatch report.It has now been populated.
Additional Manufacturer Narrative
On 11-may-2023, 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.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
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a soundstar® eco diagnostic ultrasound catheter and a foreign material was encountered.It was reported that it was discovered after the catheter was removed from the packaging that the catheter was covered in a white flaky substance.The caller stated that the white flaky substance was discovered on the shaft, connector, and handle of the catheter.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that white particles were observed on the handle of the catheter.For this reason, a fourier-transform infrared spectroscopy (ft-ir) analysis was requested and it was found that the results show that the sample analyzed is a carboxylic acid-based material.Due to this condition, an external manufacturing investigation was performed, and it was determined that this particle is from unit carton.A device history record was performed for the finished device batch number, and no internal actions were identified.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.The issue reported by the customer was confirmed.An internal corrective action has been opened to address this issue.As part of biosense webster¿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® ECO DIAGNOSTIC 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: 16777859
• Report Number: 2029046-2023-00861
• Device Sequence Number: 6849939
• Product Code: OBJ
• UDI-Device Identifier: 10846835008845
• UDI-Public: 10846835008845
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K112050
• 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,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 02/16/2024
• Device Model Number: 10439072
• Device Catalogue Number: 10439072
• Device Lot Number: G4101961
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 04/28/2023; 05/11/2023; 07/05/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/05/2023; 06/07/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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: UNK_ACUNAV
• Patient Sex: Unknown