MAUDE Adverse Event Report: HERAEUS MEDICAL SOLO PLUS STIFF HYBRID GUIDEWIRE

Catalog Number	HW35SS
Medical Device Problem Codes	Flaked (1246); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent ureteroscopy lithotripsy for kidney stones.The hybrid guidewire (b)(6) was used for the first time.It was smooth and normal when it was inserted.After a period of time, the stent was placed over the guidewire.It was found that the green coating at the end of the guidewire fell off and was wrapped with the stent, almost falling on the patient.The doctors intraoperatively communicated in between and tried every means to remove the coating, which had some impact on the clinical operation and prolonged the operation time.At the same time, the doctor had great doubts about the quality of the product.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Complete initial reporter facility name: (b)(6) hospital.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.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted received one photo sample that shows top view of guidewire with jacket removed.Therefore, the reported event is confirmed.Labeling was found to be adequate.The baw is attached in the investigation overview tab.Dhr review did not show any problems or conditions that would have contributed to the reported event.Correction; d, e, f, 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 the patient underwent ureteroscopy lithotripsy for kidney stones.The hybrid guidewire hw35ss was used for the first time.It was smooth and normal when it was inserted.After a period of time, the stent was placed over the guidewire.It was found that the green coating at the end of the guidewire fell off and was wrapped with the stent, almost falling on the patient.The doctors intraoperatively communicated in between and tried every means to remove the coating, which had some impact on the clinical operation and prolonged the operation time.At the same time, the doctor had great doubts about the quality of the product.

• Brand Name: SOLO PLUS STIFF HYBRID GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): HERAEUS MEDICAL; 5030 centerville road; st. paul
• MDR Report Key: 22522109
• Report Number: 1018233-2025-05918
• Device Sequence Number: 9231520
• Product Code: EZB
• UDI-Device Identifier: 00816840020296
• UDI-Public: (01)00816840020296(17)270807(10)9017818035
• 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: Importer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: HW35SS
• Device Lot Number: 9017818035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2025
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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