MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND SPLASHWIRE¿.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	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a procedure the wire jacket split and separated yet remained on the guidewire and was removed as a unit.No additional intervention was necessary.The patient tolerated the procedure well.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint is 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.

• Brand Name: SPLASHWIRE¿.GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 17965426
• Report Number: 9616662-2023-00018
• Device Sequence Number: 7623231
• Product Code: DQX
• UDI-Device Identifier: 00884450529447
• UDI-Public: 884450529447
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 05/19/2023
• Device Catalogue Number: MSWSTFA35260EX
• Device Lot Number: K2684166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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
• Patient Sex: Unknown