MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS BARD SOLO PLUS HYBRID GUIDEWIRE; UROLOGY GUIDEWIRE

Model Number	HW35SS
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing and inspection records did not identify any contributing factors to the failure reported.All inspection results were recorded within the specification limits.The device was received for evaluation.Results of the evaluation confirmed coating was missing.Additional information provided by the customer states that "during the case the physician mistakenly put the needle and guidewire between bladder and rectum.When he found it and withdrew the guidewire through a metal cannula, the guidewire was broken.The physician think this case may be his mishandling." the patient has recovered.The product ifu cautions the user to "carefully read and understand instructions, intended use, warnings, contraindications and precautions noted in this instructions for use (ifu) manual.Failure to do so may result in complications." the ifu also includes the warning, " do not withdraw the guidewire through a metal cannula or 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.Extreme caution should be observed when used with one-wall puncture style needle." this event happened in japan.If additional information is received, a supplemental report will be filed.This submission does not constitute a determination or admission that the device has malfunctioned or that the device was related to a death or injury.
Event or Problem Description
It was reported that "the the surface of the guidewire was flake while manipulating the device, and a flaked piece was remaining in the patient.A laparotomy was performed to remove the remaining.".

• Brand Name: BARD SOLO PLUS HYBRID GUIDEWIRE
• Common Device Name: UROLOGY GUIDEWIRE
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS; 2605 fernbrook lane n, suite j; plymouth MN 55447
• MDR Report Key: 7503889
• Report Number: 2135342-2018-00001
• Device Sequence Number: 16660920
• Product Code: EZB
• UDI-Device Identifier: 00816840020296
• UDI-Public: (01)00816840020296(17)200126(10)MO43771
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: Physician
• Device Expiration Date: 01/26/2020
• Device Model Number: HW35SS
• Device Lot Number: MO43771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention