MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT LAUREATE.GUIDE WIRE; HYDROPHILIC GUIDE WIRE

Catalog Number	AEAD35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Kidney Infection (4502)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned at a later date, the investigation will be re-opened.
Event or Problem Description
The physician alleges that post lithotripsy procedure due to urolithiasis, a medical device used during the procedure may have been responsible for a hospital acquired infection [hai].The physician is considering all medical devices used during this procedure to be a possible vector of infection.The patient was admitted 24 hours post procedure and administered iv therapy antibiotics due to pyelonephritis symptoms experienced.

• Brand Name: MERIT LAUREATE.GUIDE WIRE
• Common Device Name: HYDROPHILIC GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11592479
• Report Number: 9616662-2021-00006
• Device Sequence Number: 19860656
• Product Code: DQX
• UDI-Device Identifier: 00884450143315
• UDI-Public: 884450143315
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: AEAD35
• Device Lot Number: K1815994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention