MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® HYDRO-GLIDE¿ GUIDEWIRE

Model Number	145FS35
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device was not returned.
Event or Problem Description
It was reported that coating of the guidewire was peeling.The device was not used on the patient.
Additional Manufacturer Narrative
The reported event is unconfirmed as the problem could not be reproduced.Three unused guidewires were returned in the opened original packaging.The coating noted the coating intact on all three samples.The "flaking" referred to by the user was confirmed to be silicone jellified and adhered to the guidewire when removed from the hoops; the clumps of silicone are from the packaging process (silicone / stuff hoop).Per the work step the operator injects silicone into the hoop to make traction easier.Hydrophilic coated guidewires require activation of their coating.Prior to removing the guidewire from the protective coil, inject sterile saline through the port to activate the lubricious coating.The saline should flush away the silicone; therefore a new complaint will not be created.The samples were observed under the microscope at 30x magnification; the jellied silicone was confirmed to be present at different points on each guidewire.As no patient involvement was reported the device was not used, however, is intended for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is unconfirmed, a label/packaging review is not required.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that coating of the guidewire was peeling.The device was not used on the patient.

• Brand Name: BARD® HYDRO-GLIDE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16691267
• Report Number: 1018233-2023-02358
• Device Sequence Number: 17622565
• Product Code: EZB
• UDI-Device Identifier: 00801741053252
• UDI-Public: (01)00801741053252
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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 Model Number: 145FS35
• Device Catalogue Number: 145FS35
• Device Lot Number: GFGR1887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown