MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49945

Device Problem Knotted (1340)

Patient Problem Pain (1994)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

The area representative reported the doctor two (2) universa soft ureteral stents in a (b)(6)-old, male patient 3 months ago.The stents were both encrusted.On (b)(6) 2017 the doctor managed to remove the right stent, but the left stent knotted during the removal process.The doctor sent the patient for extracorporeal shock wave lithotripsy (eswl) in an attempt to spring the knot loose, but it failed.The patient was discharged from the hospital and due to return on (b)(6) 2017 in attempt to remove the knotted stent.The doctor asked for advice and if the manufacturer had any suggestions on this case.On (b)(6) 2017, a cystoscopy was performed threading a wire to straighten the upper pigtail.This attempt failed.The patient was left in pain as the distal end of the stent remained somewhere in the patient¿s penile shaft.A second cystoscopy was performed and the doctor managed to pull the knotted stent out using an amplatz superstiff wire with the patient under heavy sedation.As reported, the patient is well but is under close observation.

Manufacturer Narrative

Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, a review of complaint history, the device history record, instructions for use (ifu), and the device specifications.One used stent was received.The package with label information was not returned.Therefore, the reported lot number was not able to be confirmed.The device is marked 6frx 22-32cm indicating the size of the stent.The stent length measured 23cm from coil to coil.The distal coil is covered with encrustation that continues onto the stent body behind the coil.The distal coil is twisted and tangled around itself causing the stent to become knotted.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances related to the reported failure mode.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received that is associated with lot 7724874.While relatively rare, stents becoming knotted during indwell is a known issue for all stents, and is addressed in the instructions for use (ifu): "formation of knots in multi-length stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention." based on the evidence presented by the sample and the information provided by the supporting documentation, the root cause has been determined to be related to procedural and clinical factors.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7005570
• MDR Text Key: 91196942
• Report Number: 1820334-2017-03752
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499454
• UDI-Public: (01)00827002499454(17)200303(10)7724874
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: G49945
• Device Catalogue Number: USH-600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/07/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR