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	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
It was reported the end of the hydrophilic tip of the.035" hybrid wire was detached inside the patient's body during a retrograde intrarenal surgery.The detached tip was broken into multiple pieces and all pieces were retrieved by the user.The procedure was completed with a similar replacement device.There was no harm or impact to the patient reported for this event.
Additional Manufacturer Narrative
The following fields were updated: g3, g6, h2, h3, h6, h10.This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.The device evaluation, a review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The device evaluation found the device was broken in multiple pieces at the distal tip.The rest of the guidewire had debris indicating use but no further damage.The hydrophilic distal tip was broken in three separate pieces.The tip was broken about halfway up the tip and small piece of the coating had come off as well.The inner wire was broken as well.The damage of the tip was consistent with what was reported.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 was unable to be confirmed.It is possible the device was bent sharply or bent too much causing this type of damage.The ifu contains the following statements regarding this event: -"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 field performance of this device.

• 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: 11174080
• Report Number: 3003790304-2021-00010
• Device Sequence Number: 11694189
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 02/18/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1