MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS SPLASHWIRE¿..035 GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	MSWSTFA35260EX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that during a diagnostic peripheral vascular procedure after removing the.035 wire from the patient it was noted under fluoroscopy that the black jacket was starting to separate at the tip of the guidewire.The wire was immediately removed from the patient intact with no foreign body introduction.A new wire was used to complete these procedures, with no adverse consequences to the patient.The patient tolerated the procedure well.The wire was discarded at the account.
Additional Manufacturer Narrative
The suspect medical device was not returned 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 later, the investigation will be reopened.

• Brand Name: SPLASHWIRE¿..035 GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17487614
• Report Number: 9616662-2023-00012
• Device Sequence Number: 7822027
• Product Code: DQX
• UDI-Device Identifier: 00884450529447
• UDI-Public: 884450529447
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 03/10/2026
• Device Catalogue Number: MSWSTFA35260EX
• Device Lot Number: K2596688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDECATHETER INTERVENTIONAL
• Patient Sex: Unknown