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

Catalog Number	SNDSTR10
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 23-apr-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 a paroxysmal atrial fibrillation (afib) ablation procedure with a soundstar and the catheter was unable to deflect or relax completely.It was initially reported there was a deflection issue during the operation.The catheter was unable to deflect or relax completely.The customer¿s reflection issue deflection issue was not considered to be mdr reportable since the most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On 9-apr-2025, additional information was received indicating the curve was not straightening by itself when releasing the locking mechanism; it was not possible at all to return to its neutral position.Based on the new additional information which confirms the deflection was stuck, the event was reassessed as an mdr reportable malfunction.
Additional Manufacturer Narrative
It was initially reported there was a deflection issue during the operation.The catheter was unable to deflect or relax completely.The customer¿s reflection issue deflection issue was not considered to be mdr reportable since the most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.On 9-apr-2025, additional information was received indicating the curve was not straightening by itself when releasing the locking mechanism; it was not possible at all to return to its neutral position.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and deflection test of the returned device were performed.Visual inspection revealed no damage or anomalies on the device.A deflection test was performed, and no deflection issues were observed, the deflection curve could return to neutral by manually returning the catheter shaft to the neutral position using the articulation knobs, which is consistent to the provided clinical-use guidance.During the test, the catheter controls were not resistant or unable to move.A device history record evaluation was performed for the finished device lot number and no internal action was found during the review.The deflection issue reported by the customer was not confirmed as device is working as intended; this report could be customer preference related.The instructions for use include the following recommendation: if the catheter tip does not return to the neutral position after you release the steering controls, ensure the tension control knob is completely released.Release the tension by rotating the tension control knob completely in a counterclockwise direction.As part of the 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 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 21965194
• Report Number: 2029046-2025-01148
• Device Sequence Number: 8414753
• Product Code: OBJ
• UDI-Device Identifier: 10846835000139
• UDI-Public: (01)10846835000139(17)250829(10)S1535117
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070242
• 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

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: 08/29/2025
• Device Catalogue Number: SNDSTR10
• Device Lot Number: S1535117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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
• Patient Sex: Unknown