MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number G15146

Device Problem Material Separation (1562)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510k # pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during flexible cystoscopic removal of a filiform double pigtail ureteral stent set that had been indwelling for 9 months, the left stent stuck at 2/3 of entire length.Stone encrustation was also found at upper part of stent.After pulling the stent it "disrupted" leaving 1/3 of upper stent retained in the patient's body.The patient had to stay in the hospital for an unspecified length of time in order to have a laser lithotripsy to break the stone encrustation, and an ureteroscopy (urs) to remove the retained stent.No additional consequences to the patient have been reported as a result of this alleged product malfunction.Additional details have been requested about the patient and the event, at this time, no information has been provided.

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.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.Therefore, a device failure analysis could not be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, and quality control data.A review of the device history records for the set, stent component and the raw material found no related anomalies.There have been no additional complaints received on the complaint device lot at the time of this report.The device is supplied with the instructions for use (ifu) which includes the following precautions: complications of ureteral stent placement are documented.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.Do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.The stent must not remain indwelling more than twelve months.If the patient¿s status permits, the stent may be replaced with a new stent.The included stent is not intended as a permanent indwelling device.Individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.A review of manufacturing procedures found that current controls for manufacturing and quality control are in place to assure functionality and device integrity prior to shipping.The review of production processes, quality inspection documentation and the device history records did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A clinical analysis was carried out on the complaint that identified that patient anatomy is not known in this case.The fact that stents are in the urinary tract already predisposes the device to urine¿s elements.Ureteral stent encrustation is a known inherent risk of the device.In this case, the stent had been indwelling for 9 months.The longer the stent is left indwelling, the higher the likelihood for encrustation.The clinical analysis concluded at this time, the most probable contributing factor of this event is human anatomy related.The exact cause could not be established.The appropriate internal 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: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8570680
• MDR Text Key: 143806443
• Report Number: 1820334-2019-00915
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)190525(10)6997009
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2019
• Device Model Number: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 6997009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLEXIBLE CYSTOSCOPE
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 68 YR
• Patient Weight: 60