MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER; SIMILAR DEVICE SNDSTR10, 510K # K070242

Model Number M-5723-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant product: siemens acuson sc2000 echo machine.(b)(4).

Event Description

A medwatch was received in the biosense webster complaints management department.The medwatch form stated that the soundstar catheter failed to initialize during an emergency pericardiocentesis in the context of left ventricular perforation secondary to premature ventricular contraction (pvc) ablation.No other therapies were used on the patient.No other devices were used on the patient, although, it was originally thought that it may have been the siemens acuson sc2000 echo machine.The defective catheter was used in conjunction with this echo machine.There is no further information about the hospitalization.No information was known regarding the patient status.The physician's opinion on the cause of this adverse event was unknown.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

• Brand Name: SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER
• Type of Device: SIMILAR DEVICE SNDSTR10, 510K # K070242
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5234911
• MDR Text Key: 31576532
• Report Number: 2029046-2015-00263
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5723-00
• Device Catalogue Number: M572300
• Device Lot Number: OEM_M-5723-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention