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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INNOVATIVE HEALTH, LLC.; DIAGNOSTIC ULTRASOUND CATHETER
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INNOVATIVE HEALTH, LLC.; DIAGNOSTIC ULTRASOUND CATHETER Back to Search Results
Model Number D087031
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/01/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Innovative health, llc became aware on 08-oct-2021 of a report from (b)(6) hospital on a viewflex xtra ice device that experienced a broken tip while in use during a procedure.No patient injuries were reported.Additional feedback from the hospital was unavailable.Upon receipt of the device, the distal tip was confirmed to be broken.The fractured tip remained attached to the device.No further damage was identified on the device.
 
Event or Problem Description
The tip of this device was reported to be broken during the procedure.No patient injuries were reported.
 
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Brand Name
NA
Common Device Name
DIAGNOSTIC ULTRASOUND CATHETER
Manufacturer (Section D)
INNOVATIVE HEALTH, LLC.
1435 north hayden road
suite 100
scottsdale AZ 85257
MDR Report Key12700995
Report Number3011610434-2021-00017
Device Sequence Number17303561
Product Code OWQ
UDI-Device Identifier10841898123252
UDI-Public10841898123252
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
K202042
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/26/2021
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 Date02/22/2022
Device Model NumberD087031
Device Catalogue NumberD087031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2021
Initial Report FDA Received Date10/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 Yes
Patient Sequence Number1
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