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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT LAUREATE GUIDEWIRE; HYDROPHILIC GUIDEWIRE
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MERIT MEDICAL SYSTEMS MERIT LAUREATE GUIDEWIRE; HYDROPHILIC GUIDEWIRE Back to Search Results
Catalog Number LWSTDS35150/D
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 07/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event or Problem Description
The account alleges that during a ureteroscopy procedure, 10cm of the hydrophilic guide wire's coating detached within the patient's ureter.A new guidewire was used to complete the procedure.
 
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Brand Name
MERIT LAUREATE GUIDEWIRE
Common Device Name
HYDROPHILIC GUIDEWIRE
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS
parkmore business park west
ballybrit, galway
EI 
MDR Report Key10985345
Report Number9616622-0200-00018
Device Sequence Number3019242
Product Code DQX
UDI-Device Identifier00884450033319
UDI-Public884450033319
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K141295
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/02/2020
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 Expiration Date06/10/2019
Device Catalogue NumberLWSTDS35150/D
Device Lot NumberK1589414
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/02/2020
Initial Report FDA Received Date12/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
UERTEROSCOPE
Outcome Attributed to Adverse Event Required Intervention;
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