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

Model Number	10438577
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not returned for analysis, however, 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.Manufacturer's reference number: pc-(b)(4).
Event or Problem Description
It was reported that a soundstar® eco diagnostic ultrasound catheter was received and it was observed that there was an open pouch seal issue.The shipping box for the soundstar® eco diagnostic ultrasound catheter arrived damaged.The outside shipping box appeared to have been stuck on some kind of conveyor belt, as there was a hole burned through the shipping box, straight through to the catheter box, and the catheter handle was exposed.It was reported that they could stick their finger through the hole on the shipping box, and physically touch the catheter handle, confirming the sterility was compromised.There was no patient involvement.The packaging damaged issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The issue with the catheter box that compromised the sterility of the product was assessed as a mdr reportable open pouch seal issue.
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4) after further review on 15-jun-2021 of the reported event it was determined that the event was initially assessed as a mdr reportable malfunction of "tear, rip or hole in device packaging (a020504)" which was incorrect.This event has now been correctly assessed as a "distribution/delivery service" issue.Which is not considered to be mdr reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 5/27/2021.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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
• MDR Report Key: 11853605
• Report Number: 2029046-2021-00785
• Device Sequence Number: 4016747
• Product Code: OBJ
• UDI-Device Identifier: 10846835008838
• UDI-Public: 10846835008838
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2021

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: 02/14/2022
• Device Model Number: 10438577
• Device Catalogue Number: 10438577
• Device Lot Number: E5102137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 05/27/2021; 06/15/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/02/2021; 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SOUNDSTAR ECO SMS 10F CATHETER