MAUDE Adverse Event Report: COOK INC HARRISON FETAL BLADDER STENT SET; MPR STENT,BLADDER,FETAL

Model Number	G16766
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - phone: (b)(6).E3 - occupation: nursing assistant.H3 - device evaluation anticipated but not yet begun.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.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.
Event or Problem Description
It was reported that the harrison fetal bladder stent set was difficult to advance during a left pleuro-amniotic drainage procedure for a 34-year-old, female patient that was 22 weeks and 2 days of gestation.The patient was admitted for an in-utero placement of a left pleuro-amniotic drainage tube in the context of hydrothorax.During the procedure, the user was not able insert the pleural drain with the stylet attached into the trocar.A new similar-like device was used to complete the procedure.The device was tested prior to use.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• Brand Name: HARRISON FETAL BLADDER STENT SET
• Common Device Name: MPR STENT,BLADDER,FETAL
• 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: 25046942
• Report Number: 1820334-2026-00465
• Device Sequence Number: 9781240
• Product Code: MPR
• UDI-Device Identifier: 00827002167667
• UDI-Public: (01)00827002167667(17)281204(10)16893553
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: H960001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: G16766
• Device Catalogue Number: J-HFBS-503540
• Device Lot Number: 16893553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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 Age: 34 YR
• Patient Sex: Female