MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC. N/A; DIAGNOSTIC ULTRASOUND CATHETER

Model Number	D087031
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Innovative health llc became aware on (b)(6) 2025 of a reprocessed viewflex xtra ice diagnostic ultrasound catheter reported to have poor image quality reported during the transseptal puncture in a procedure.The device was reported to have been in use when a coronary perforation and subsequent pericardial effusion.This required the placement of an epicardial drain.The catheter was discarded by the facility and no device details were provided.Additional details were received on 14-aug-2025 regarding the event.While the reprocessed viewflex device was reported to have image quality issues during the case, it was reported that the brk transseptal needle in use (from a different medical device manufacturer) was responsible for the transseptal puncture resulting in the perforation and pericardial effusion.No further medical intervention was necessary for this case beyond the epicardial drain.The patient recovered and was discharged on the same day.No additional device details were able to be obtained for any of the devices used in the procedure.As the device was not returned for investigation nor were any device details provided, no further investigation was able to be completed.With the information available, innovative health cannot confirm any performance issues with the reprocessed viewflex xtra diagnostic ultrasound catheter.
Event or Problem Description
A reprocessed viewflex device was reported to have been used during a procedure where a perforation occurred resulting in a pericardial effusion.It was reported that a brk transseptal needle from a different manufacturer was also in use at the time of the event.

• Brand Name: N/A
• Common Device Name: DIAGNOSTIC ULTRASOUND CATHETER
• Manufacturer (Section D): INNOVATIVE HEALTH, LLC.; 1435 north hayden road; suite 100; scottsdale AZ 85257
• Manufacturer (Section G): INNOVATIVE HEALTH, LLC.; 1435 north hayden road; suite 100; scottsdale AZ 85257
• Manufacturer Contact: rebecca sturm ; 1435 north hayden road; suite 100; scottsdale, AZ 85257
• MDR Report Key: 22904928
• Report Number: 3011610434-2025-00004
• Device Sequence Number: 15686363
• Product Code: OWQ
• UDI-Device Identifier: 10841898123252
• UDI-Public: 10841898123252
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K202042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: D087031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown