MAUDE Adverse Event Report: HERAEUS MEDICAL SOLO FLEX HYBRID GUIDEWIRES

Catalog Number	HW35FA
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
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 the customer was undergoing ureteroscopy, a guide wire was used to establish a working channel.During the operation, the guide wire was pulled out and placed in the basin on the operating table.When the operation was almost over, the guide wire was activated and used to place a ureteral stent.It was found that the stent could not be pushed in, and the sheath of the guide wire fell off.A new guide wire was replaced, and the stent was successfully placed.Patient has been exposed to hazardous materials, blood or body fluids.It was unknown what medical intervention was provided.Per follow up information received via ibc on 04mar2025, stated that the patient was not harmed by the device.The ureteral sheath has not fallen off.
Additional Manufacturer Narrative
The reported event is inconclusive.Visual evaluation noted received one photo sample shows top view of guidewire within guidewire holder.As the photo sample received cannot be tested for the reported event the reported event is inconclusive.The labelling was reviewed and found to be adequate.Dhr review did not show any problems or conditions that would have contributed to the reported event.Correction: d, f, g, 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 the customer was undergoing ureteroscopy, a guide wire was used to establish a working channel.During the operation, the guide wire was pulled out and placed in the basin on the operating table.When the operation was almost over, the guide wire was activated and used to place a ureteral stent.It was found that the stent could not be pushed in, and the sheath of the guide wire fell off.A new guide wire was replaced, and the stent was successfully placed.Patient has been exposed to hazardous materials, blood or body fluids.It was unknown what medical intervention was provided.Per follow up information received via ibc on 04mar2025, stated that the patient was not harmed by the device.The ureteral sheath has not fallen off.

• Brand Name: SOLO FLEX HYBRID GUIDEWIRES
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): HERAEUS MEDICAL; 5030 centerville road; st. paul 55127
• 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: 21547561
• Report Number: 1018233-2025-01523
• Device Sequence Number: 17925536
• Product Code: EZB
• UDI-Device Identifier: 00816840020357
• UDI-Public: (01)00816840020357(11)240305(17)270305(10)9017043242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HW35FA
• Device Lot Number: 9017043242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Report to Manufacturer: 03/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• 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