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

Model Number	G32774
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a pyeloplasty on (b)(6) 2022, a salle pyeloplasty stent set was placed without a wire.On (b)(6) 2022, the stent was removed with the use of probe ablation, but the device was discovered to be separated, with half of the device remaining in the patient's kidney.During another procedure the same day, the remaining device segment was successfully removed from the patient via surgical incision.The stent was not encrusted.The patient was hospitalized one additional day following the stent removal.No adverse affects to the patient have been reported as a result of this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during a pyeloplasty on (b)(6) 2022, a salle pyeloplasty stent set was placed without a wire.On (b)(6) 2022, the stent was removed with the use of probe ablation, but the device was discovered to be separated, with half of the device remaining in the patient's kidney.During another procedure the same day, the remaining device segment was successfully removed from the patient via surgical incision.The stent was not encrusted.The patient was hospitalized one additional day following the stent removal.No adverse affects to the patient have been reported as a result of this event.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned with no original packaging in a specimen jar.The device was separated in two segments.No encrustation was noted on either of the two segments.One of the edges of separation was a clean break, and the other end appeared stretched.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which include ¿absence or severe reduction of kidney function¿ as a contraindication for device use and encrustation and breakage/erosion as potential adverse events.Based on the available information, cook has concluded that a cause for this event could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 13599281
• Report Number: 1820334-2022-00310
• Device Sequence Number: 13942282
• Product Code: FAD
• UDI-Device Identifier: 00827002327740
• UDI-Public: (01)00827002327740(17)221203(10)10186125
• Combination Product (Y/N): N
• Initial Reporter Country: MB
• PMA/510(K) Number: K170010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2022

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 Expiration Date: 12/03/2022
• Device Model Number: G32774
• Device Catalogue Number: SIPSF-050018-59
• Device Lot Number: 10186125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male