MAUDE Adverse Event Report: GYRUS ACMI, INC. 0.038" HYBRID WIRE, BOX OF 5; STYLET, URETERAL

Model Number	GWH3805R
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported during a therapeutic foley catheter placement, the subject device frayed on removal within the catheter tubing.The patient was being catheterized post-operatively in the pacu because they were not spontaneously voiding.Urology was contacted to insert the catheter to avoid urethral trauma.While advancing an 18 french coude foley catheter into the urethra, resistance was met at the expected position of the bulbar urethra and the catheter was removed.Next the subject device was advanced into the bladder and a 5 french pollack catheter was used to confirm positioning in the bladder.Then a 6 french council tip catheter was attempted to be advanced over the wire however similar resistance was encountered at the level of the bulbar urethra and the catheter was removed.Next a 14 french silicone catheter was used as a council tip catheter by puncturing the tip with the angiocatheter; this was then advanced over the wire into the bladder with a return of more than one (1) liter of clear yellow urine.Upon removal of the subject device, the wire frayed within the catheter tubing.Since the wire could not be removed in it's entirety, the catheter and the wire were removed together atraumatically.A kub confirmed removal of the wire.The customer reported it is unknown if the subject device was inspected prior to use.
Additional Manufacturer Narrative
This supplement is being submitted to update the reportability status of the event per the legal manufacturer.The new information was added to b1.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the device evaluation, legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The olympus service center evaluated the device and found the following: the device was visual inspected and it was confirmed to have many areas frayed and different components unraveling/loose.In addition, the wires had many unnatural bends and dents.Along with the wires, the end of the clear plastic tubing appears to have a tear as if it was caught on something sharp.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the wire jammed during application and was pulled with high force, which exceeded the specified load limit and thus led to the breakage of the connection between the spring and the core wire.This then caused the spring to unravel.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Common Device Name: STYLET, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave. north; brooklyn park MN 55445
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 13031143
• Report Number: 3003790304-2021-00196
• Device Sequence Number: 4144413
• Product Code: EYA
• UDI-Device Identifier: 00821925031449
• UDI-Public: 00821925031449
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: GWH3805R
• Device Lot Number: 91706349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/28/2022; 03/16/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/28/2022; 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown