MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SOLO PLUS STIFF HYBRID GUIDEWIRES

Catalog Number	HW35SAJ
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that when customer started using guidewire, the tip broke off immediately.All items from the same lot were collected, and the customer requested that all be investigated.A total of 4 bottles were in storage, but 3 of the 4 are unopened.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted this investigation of these devices was performed in two parts.The first part was to characterize the damaged guidewire.The second part was to determine the whether the other 3 guidewires would have the same or similar failure mode.After the sample analysis, it was concluded the following information: the core wire does appear to have broken, and the investigation confirms this.None of the unused units had a core break or fracture because of our testing and they all tested within specifications and did not break.The polymer appeared to be sheared perpendicular to the axis/core.It was hard to tell by looking at the ¿broken¿ ends, but when the polymer was cut back, the core was shown to be present.We also profiled the units and saw nothing that would lead us to believe there was a break in the wire that could be caused during our process.No actions can be taken at this time since a root cause was not identified.Dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and states the following: contraindication & prohibition 1.Method of use (1) single use only (2) do not re-sterilize.Shape, configuration and principles 1.Configuration there are two types of the candidate device based on the stiffness of core wire, plus type and flex type.Flex type has the core wire made of ni-ti alloy and plus type has the core wire made of ni-ti-co alloy which is stiffer than ni-ti.In addition, there are two tip shapes for each type, straight tip and angled tip hoop in order to completely wet the surface of the guidewire.(2) remove the guidewire from the protective hoop.(3) the guidewire may be introduced into the patient body in any of the following manners.A) place the guidewire via a scope into the ureter first before placing a catheter over the guidewire.B) preload a catheter over the guidewire and place as a complete unit into the ureter.C) back-load the guidewire through a preplaced catheter.(4) carefully and slowly withdraw the guidewire from the patient to avoid any kinking.2.Precaution related to method of use (1) when wetting the surface of the guidewire, use of alcohol, antiseptic solution or other solvents must be avoided [alcohol, antiseptic solution or other solvents may adversely affect the surface of the guidewire.(2) save the hoop to store the guidewire if it will be used again during the same procedure on the same patient.When reinserting the guidewire back into the holder, take care not to damage the wire¿s coating with the edge of the holder.(3) do not wipe the guidewire with dry gauze etc.(4) keep at least 5 cm of the wire extended out of the proximal end of the scope or catheter during introduction at all times.(5) before inserting the guidewire through a catheter, fill the catheter with physiological saline solution.(6) the guidewire should be advanced through the scope using short, deliberate 2-3 cm movements to prevent inadvertent damage to the device or patient.(7) if any resistance is felt during introduction of the catheter, it is advisable to stop using such catheters.[due to variations of certain catheter tip inner diameters, abrasion of the hydrophilic coating may occur during manipulation.(8) after removal from the patient¿s urinary system, and prior to reinserting it into the same patient during the same catheterization, hydrophilic tipped guidewires should be rinsed in a bowl full of physiological saline solution.Use of alcohol, antiseptic solutions or other solvents must be avoided.Use of alcohol, antiseptic solutions or other solvents may adversely affect the surface of the guidewire.Precaution 1.Important, basic precautions (1) do not withdraw the guidewire through a metal cannula or needle.Extreme caution should be observed when used with one-wall puncture style needle.[withdrawal through a metal device may result in disposition of these materials in the urinary system and destruction and/or separation of the outer polymer jacket requiring retrieval.(2) use extreme caution when using a laser or electrocautery, making sure to avoid contact with the guidewire.Direct contact may cause damage to the wire and/or sever the wire.(3) do not use a torque device with the guidewire.Use of a torque device may result in damage to the wire.(4) do not reshape the guidewire in any way.Attempting to reshape the wire may cause damage, resulting in the release of wire fragments to the urinary system.(5) when exchanging or withdrawing a catheter over the guidewire, secure and maintain the guidewire in place under fluoroscopy to avoid unexpected guidewire advancement.Damage to the urinary channel by the wire¿s tip may occur.(6) manipulate the guidewire slowly and carefully in the urinary system while confirming the behavior and location of the wire¿s tip under fluoroscopy.If any resistance is felt or if the tip¿s behavior and or location seems improper, stop manipulating the guidewire and or the catheter and determine the cause by fluoroscopy.If necessary, remove the guidewire and ancillary device or scope as a complete unit to avoid complications.[excessive manipulation of the guidewire without fluoroscopic confirmation may result in perforation or trauma of the linings or associated tissues, channels or ducts.Failure to exercise proper caution may result in bending, kinking, and separation of the guidewire¿s tip, damage to the catheter, or damage to the urinary system.2.Device malfunction and adverse event (1) device malfunction fracture difficult to pass for guidewire (2) adverse event perforation of the urinary tract bleeding tissue trauma edema foreign object in body infection hemoglobinuria peritonitis ureter avulsion method of storage and expiration period 1.Method of storage keep this device in a cool and dry place.Avoid a hot/humid place and direct sunlight.2.Expiration period expiration date is described on the package.Correction- d, e ,h.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that when customer started using guidewire, the tip broke off immediately.All items from the same lot were collected, and the customer requested that all be investigated.A total of 4 bottles were in storage, but 3 of the 4 are unopened.

• Brand Name: SOLO PLUS STIFF HYBRID GUIDEWIRES
• 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: 20925904
• Report Number: 1018233-2024-07999
• Device Sequence Number: 12025922
• Product Code: EZB
• UDI-Device Identifier: 00816840020463
• UDI-Public: (01)00816840020463(11)231107(17)260921(10)9016235316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 09/21/2026
• Device Catalogue Number: HW35SAJ
• Device Lot Number: 9016235316
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown