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

Model Number 10439011

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a soundstar eco 8fg ultrasound catheter, soundstar eco 8f ultrasound catheter and a broken tip issue occurred.The tip of the soundstar catheter was broken on intra-op.While starting sound mapping, and the physician said that the tip of the catheter was broken so he could not manipulate the catheter properly.It was confirmed that the tip of the catheter was broken, and the catheter was changed, and the issue resolved with no soundstar catheter error.The procedure was completed successfully.With the information available, this was assessed as a mdr reportable broken tip issue.

Manufacturer Narrative

Additional information was received on 4/30/2021.It was reported that the damage did not result in wires being exposed or any lifted or sharp rings.According to the physician, the catheter was not curved well.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was pre-shaped.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4) initially, this event was assessed as mdr reportable for a broken tip issue.During an internal review on (b)(6) /2021, a correction was noted to the assessment as this event should have been assessed as deflection issue which is not mdr reportable.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.Therefore, the h6.Medical device problem code was changed from break (a0401) to positioning problem (a1502).

• Brand Name: SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11672298
• MDR Text Key: 268142359
• Report Number: 2029046-2021-00584
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 10846835008852
• UDI-Public: 10846835008852
• Combination Product (y/n): N
• PMA/PMN Number: K140318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Model Number: 10439011
• Device Catalogue Number: 10439011
• Device Lot Number: E8266477
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1