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

Model Number	GWH3505R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is still under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
It was reported the hydrophilic coating of the.035" hybrid wire was detached inside the patient's body during a retrograde intrarenal surgery.The coating was reported to be detached at the middle and in multiple pieces.The user was able to retrieve all of the pieces.The procedure was completed with a similar device.No patient harm or impact was reported due to this occurrence.
Additional Manufacturer Narrative
D4: the device lot was updated to the lot found on the returned label.This supplemental report is being submitted to provide the results of the manufacturer's investigation.An evaluation of the device, a review of the device history record (dhr), and a review of the instructions for use (ifu) was conducted as part of the investigation.The device was returned with the original packaging.The device was coiled in the original protective hoop.The thumb advance inducer was not returned.The guidewire was inspected and there was damage on the hydrophilic tip.The rest of the guidewire did not show any visible damage.The damage on the tip was a small piece of the hydrophilic coating missing.The inner wire of the tip was not exposed.The missing piece was near the base of the coating, where the floppy tip connects to the main guidewire.The hydrophilic coating had some cracking throughout the whole tip.The damage of the coating was confirmed, however it is very unlikely that this coating was broken in multiple pieces.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The root cause of the damage was unable to be confirmed.A possible cause is sharp bending of the device causing this damage.The ifu contains the following statements: "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." olympus will continue to monitor for similar events.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Common Device Name: STYLET, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11174550
• Report Number: 3003790304-2021-00012
• Device Sequence Number: 3727076
• Product Code: EYA
• UDI-Device Identifier: 00821925031425
• UDI-Public: 00821925031425
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT-EYA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: Health Professional
• Device Model Number: GWH3505R
• Device Lot Number: 92000247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1