MAUDE Adverse Event Report: MERIT MEDICAL, INC TENOR®; WIRE, GUIDE, CATHETER

Model Number	00884450093641
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The account alleges that during prostate artery embolization intervention, the guidewire fractured at the distal end.The provider attempted to remove both the tip of the guidewire with a snare, which was unsuccessful.The decision was made to leave the tip of the wire in the prostate artery.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed and the root cause is attributed to clinical use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: TENOR®
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MERIT MEDICAL, INC; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer (Section G): MERIT MEDICAL, INC; bat. a- parc des nations; 383 rue de la belle etoile; roissy charles de gaulle, cedex 95958 ; FR 95958
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15331376
• Report Number: 9615728-2022-00002
• Device Sequence Number: 20132962
• Product Code: DQX
• UDI-Device Identifier: 00884450093641
• UDI-Public: 00884450093641
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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
• Device Model Number: 00884450093641
• Device Catalogue Number: TNR2411
• Device Lot Number: 6229033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown