MAUDE Adverse Event Report: GYRUS ACMI, INC 0.035" HYBRID WIRE, BOX OF 5; GUIDEWIRE

Model Number GWH3505R

Device Problems Break (1069); Detachment Of Device Component (1104); Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been discarded by the facility.As a result, a determination cannot be made at this time.If further information becomes available, gyrus acmi will continue the investigation and update the agency accordingly.Device was discarded.

Event Description

Boston scientific stent placed over ultratrack guidewire.During insertion, floppy distal tip of guidewire broke off and was left inside patient.Guidewire and stent removed and wire frayed.Distal tip left in patient removed separately after by doctor.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the dhr review performed.Based on the dhr review the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): GYRUS ACMI, INC; ermsim schwoltbogen 24; dettingen, 72581
• MDR Report Key: 7455171
• MDR Text Key: 107088385
• Report Number: 3005975494-2018-00005
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GWH3505R
• Device Lot Number: 91702106
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention