MAUDE Adverse Event Report: COOK INC UROSTREAM HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number	UROS-035150-S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation - (b)(6).G4: pma/510(k) number - exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
As reported, during a ureteroscopy (urs) and laser lithotripsy, the urostream hydrophilic wire guide shredded.Saline was passed through the wire housing to activate the coating.The coating of the device was reactivated before using the wire guide for a second pass.During the second pass of the wire guide, pieces of wire guide jacket were coming off.The physician expressed that the wire was beginning to feel tacky.An ncircle stone extractor was used to remove the separated pieces of the device from the patient, during the same procedure.A motion wire guide was then used to complete the procedure as normal.No section of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation as reported, during a ureteroscopy (urs) and laser lithotripsy, the urostream hydrophilic wire guide shredded.Saline was passed through the wire housing to activate the coating.The coating of the device was reactivated before using the wire guide for a second pass.During the second pass of the wire guide, pieces of wire guide jacket were coming off.The physician expressed that the wire was beginning to feel tacky.An ncircle stone extractor was used to remove the separated pieces of the device from the patient, during the same procedure.A motion wire guide was then used to complete the procedure as normal.No section of the device remained inside the patient.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as and a visual inspection of the device were conducted.One urostream hydrophilic wire guide was returned without packaging or labeling.Delamination of the wire guide jacket was observed in two sections of the wire guide.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search identified one other complaint associated with the reported device lot with an unrelated failure mode.The evidence from the complaint file, device history record, complaint history and quality control documents indicate that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The ifu supplied with the device, t_uros_rev0 was reviewed and includes the following: precautions ¿ end hole size and length of device must be taken into consideration to ensure a proper fit between the wire guide and the procedural device.¿ manipulation of the wire guide requires appropriate imaging control.Use caution not to force or overmanipulate the wire guide when gaining access.¿ when using the wire guide through a metal cannula or needle, use caution, or damage may occur to the outer coating of the wire guide.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a cause for the complaint cannot be established, it was not possible to rule out the wire guide being damaged inadvertently by another device during the procedure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UROSTREAM HYDROPHILIC WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18499581
• Report Number: 1820334-2024-00064
• Device Sequence Number: 12749775
• Product Code: OCY
• UDI-Device Identifier: 00827002591530
• UDI-Public: (01)00827002591530(17)260418(10)CINC003456
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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 Expiration Date: 04/18/2026
• Device Catalogue Number: UROS-035150-S
• Device Lot Number: CINC003456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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
• Patient Sex: Unknown