MAUDE Adverse Event Report: HERAEUS MEDICAL COMPONENTS, LLC SOLO PLUS HYBRID GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number HW38SA

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for physical analysis, therefore no device evaluation could be performed.Heraeus is unable to comment on the condition of the device or the cause of the occurence.If additional information is received, a follow up report will be submitted.

Event Description

It was reported that the guidewire broken off in the patient during a procedure on (b)(6) 2019 and was not discovered until the patient complained about pain after the procedure but the cause was unknown.The patient had to do a secondary procedure on an unknown date to remove the guidewire.

• Brand Name: SOLO PLUS HYBRID GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): HERAEUS MEDICAL COMPONENTS, LLC; 2605 fernbrook lane north; suite j; plymouth MN 55447
• Manufacturer Contact: chelsea becker ; 2605 fernbrook lane n; suite j; plymouth, MN 55447 ; 7632526500
• MDR Report Key: 8813191
• MDR Text Key: 151776804
• Report Number: 2135342-2019-00001
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00816840020326
• UDI-Public: (01)00816840020326(17)200308(10)MO44542
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/11/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: HW38SA
• Device Catalogue Number: HW38SA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2019
• Initial Date FDA Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention