MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD. INQWIRE.GUIDE WIRE

Model Number	00884450021576
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during incoming inspection of the guidewire packaging, an open seal was identified compromising the sterility of the wire.A new guidewire was used to complete the procedure.No patient contact or injury to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the transport and handling process.A search of the complaint database was performed and one similar complaint for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: INQWIRE.GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore business park west; galway, ballybrit ; EI
• MDR Report Key: 10059720
• Report Number: 9616662-2020-00009
• Device Sequence Number: 14182260
• Product Code: DQX
• UDI-Device Identifier: 00884450021576
• UDI-Public: 00884450021576
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 02/28/2023
• Device Model Number: 00884450021576
• Device Catalogue Number: IQ35F180J3/B
• Device Lot Number: K1791811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1