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

Model Number GWH3505R

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.In addition, insufficient information was provided by the user facility.Multiple follow ups were made by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained.The cause of the reported event cannot be determined at this time.However, the instruction manual contains several warning and caution statements in an effort to prevent damage to the guidewire." inspect the device for any visible damage such as kinks, unwound coil, abrasion at the tip etc.Carefully and slowly withdraw the guidewire from the patient to avoid any damage.The tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating material be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.¿.

Event Description

Olympus was informed that during a procedure, the doctor inserted the device into the patient¿s kidney and when the doctor went to remove the device it could not be removed.The doctor had to remove the entire stent and then the device became ¿unraveled¿.The doctor used a second device from the same lot and the second device also failed as well.The procedure was completed using a non-olympus device.There was no injury reported.1 of 2 devices.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation results.During evaluation it was noted that the distal prebax tip remained attached to the coil which was stretch off over the distal 25cm of the corewire.The corewire was intact and free from damage but the prebax tip/coil were no longer bonded to the distal end of the corewire.The proximal sleeve and coil section were intact over the corewire with the coil secured at the transition.Based upon observations, it is believed that the initial point of failure occurred at the distal prebax tip section adjacent to the coil transition.The failure mode is consistent with previous complaints where the ultratrack's prebax tip, near the coil transition, likely became unbound within a deployed stent while attempting to retract the guidewire from the stent.Continued retraction force applied to the bound guidewire after the initial failure resulted in the progressive damage to the coil.Additionally, a review of the device history record (dhr) was conducted by the original equipment manufacturer (oem) and indicated the production of the involved lot has been done according to the valid specifications.All process steps and all inspections have been done as prescribed.The device's instruction for use manual provides warning and caution which states, "do not apply excessive force to advance or withdraw the guidewire.Doing so may result in complications.If resistance is encountered, determine the cause and take remedial action before continuing.".

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Type of Device: GUIDE WIRE, HYBRID
• Manufacturer (Section D): GYRUS ACMI, INC; ermsim schwoltbogen 24; dettingen, 72581
• MDR Report Key: 8210752
• MDR Text Key: 132509608
• Report Number: 2951238-2019-00318
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3505R
• Device Lot Number: 91706356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT (MODEL, SN UNKNOWN)