MAUDE Adverse Event Report: COOK INC SALLE PYELOPLASTY STENT SET; FAD STENT, URETERAL

Model Number	G32774
Medical Device Problem Codes	Peeled/Delaminated (1454); Difficult to Remove (1528)
Health Effect - Clinical Codes	Hematuria (2558); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight = 8.2 kg.B3: date of event: exact date is unknown.Occurred during the week of 10feb2025.E1: phone number = (b)(6); facility phone number = (b)(6).E3: occupation = (b)(6).H3: device not returned to the manufacturer.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 during a pyeloplasty procedure, the wire guide included in the 'salle intraoperative pyeloplasty stent set' became snagged inside the stent making it difficult to remove.The patient has subsequently passed some green material in the urine which is the same color as the coating.As reported, the stent was inserted over the guidewire which had been cut to remove the second coil.Upon withdrawal, it initially came out smoothly but then became difficult to remove causing the stent to concertina and coil up.The wire was eventually removed, the stent was checked for proper positioning and the procedure was completed.The patient seemed fine and was discharged from the hospital.Later, the baby had a green gritty sediment in the nappy.The parents contacted the physician, and the baby was brought back to the hospital for a plain x-ray to ensure there wasn't anything left in the bladder.The stent was removed 3 days earlier than planned, where it was found that it had a slight green tinge to it.No additional patient consequences have been reported.
Event or Problem Description
Correction: the only reported device malfunction was 'difficult removal' and there is no indication that the reported device malfunction caused or contributed to a serious injury.Although hematuria was not explicitly reported, it is observable in the submitted photo.Hematuria is a well-documented, expected side effect of stent placement; additionally, this patient had a known pre-existing condition of ureteric stricture, which further supports hematuria as an expected outcome unrelated to a malfunction.A comprehensive complaint history review revealed no prior events of this failure mode resulting in serious injury or death.Based on this updated evaluation, the event no longer meets the criteria for reporting under 21 cfr part 803, as it does not involve death, serious injury, or a reportable malfunction that is likely to cause or contribute to such outcomes.
Additional Manufacturer Narrative
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.

• Brand Name: SALLE PYELOPLASTY STENT SET
• Common Device Name: FAD STENT, URETERAL
• 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: 21531868
• Report Number: 1820334-2025-00223
• Device Sequence Number: 15217593
• Product Code: FAD
• UDI-Device Identifier: 00827002327740
• UDI-Public: (01)00827002327740(17)270118(10)15854569
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K170010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

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: G32774
• Device Catalogue Number: SIPSF-050018-59
• Device Lot Number: 15854569
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2024
• 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: 3.0 VICRYL STAY SUTURES (REMOVED BEFORE CLOSURE).; 6.0 PDS SUTURE.
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 8 KG