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

Catalog Number UROS-035150

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 Description

As reported, the coating of a 'urostream hydrophilic wire guide' sheared off during a percutaneous nephrolithotomy (pcnl) procedure.An 18g chiba biopsy needle was used in an attempt to gain access through the kidney to the bladder.The coating of the wire guide was activated with sterile water.The wire guide was advanced through the needle and it was noted that the coating of the wire guide sheared off.The user reported no resistance when advancing or retracting the wire guide through the needle.The user accessed the collecting system and retrieved the fragment with reusable graspers from the device tray.The user removed the device and replaced it to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, the coating of a 'urostream hydrophilic wire guide' sheared off during a percutaneous nephrolithotomy (pcnl) procedure.An 18g chiba biopsy needle was used in an attempt to gain access through the kidney to the bladder.The coating of the wire guide was activated with sterile water.The wire guide was advanced through the needle and it was noted that the coating of the wire guide sheared off.The user reported no resistance when advancing or retracting the wire guide through the needle.The user accessed the collecting system and retrieved the fragment with reusable graspers from the device tray.The user removed the device and replaced it to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), manufacturing instructions, and quality control procedures.One urostream hydrophilic wire guide was returned in a ziploc bag with a small label attached.A section of the wire guide jacket was returned separate from wire guide approximately 13.7cm long.The inner core was visible on the wire guide where the jacket separated approximately 11.7cm from the tip.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 device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: 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, it was determined the cause of the complaint is likely related to unintended user error when using the wire guide through a needle.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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
• Type of Device: 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: 18358029
• MDR Text Key: 330900932
• Report Number: 1820334-2023-01736
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002591516
• UDI-Public: (01)00827002591516(17)260308(10)CINC003148
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UROS-035150
• Device Lot Number: CINC003148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK 18G CHIBA BX NEEDLE