MAUDE Adverse Event Report: COOK INC KWART RETRO-INJECT URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number 003600

Device Problems Failure to Unfold or Unwrap (1669); Deformation Due to Compressive Stress (2889)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Pma/510k # non- exempt 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 that the kwart retro-inject ureteral stent set was placed during an operative intervention involving a ureteral stone.After an unknown period of time, a removal attempt of the kwart retro-inject ureteral stent in china failed as the proximal pigtail had formed a knot and prevented the extraction of the stent.The patient required an unknown additional operative intervention to remove the device.Patient outcome post-procedure is unknown at this time.

Manufacturer Narrative

Investigation: evaluation: customer returned one used mlssf-060022-32-kwt-aq multi length stent covered with dried blood and bodily fluid.Visual examination confirmed the distal multi coil is tied into a knot 3cm from the end.No other anomalies were observed.Imaging was provided for review.Per the imaging review, it does demonstrate the proximal portion of the double j ureteral stent tied in a knot.The knot is tightened down enough to collapse the stent lumen, indicating a decent amount of force was applied to the catheter when trying to remove it.There is no discussion if the removal was performed under fluoroscopic guidance or done just under direct visualization with the cystoscope as it was going to just be a removal.There is nothing in the stent design that prevents the proximal or distal portions of the stent from becoming entwined with itself.During placement, if the renal pelvis is not distended or capacious, as the stent is fed off of the wire and forms its proximal loop, the free end may thread through the proximal loop as it is formed.Alternatively, if the stent is inadvertently twisted during the removal, this may encourage the free end of the stent to flip through the loop formed in the renal pelvis and result in a knot if continued retraction of the stent is performed.To avoid this situation, using fluoroscopy, one can see if the knot begins to form in the proximal loop and the distal end of the stent can be brought external to the patient, if long enough, and a wire can be inserted through the stent to help open the loop and prevent a tight knot formation.In addition, even if the knot has loosely formed, inserting a wire though the stent will often result in unfurling of the knotted end of the stent.Neither of these maneuvers were described in the complaint report.Unfortunately, it seems the operators could not undo the knot once it was formed and required an additional procedure to remove the knotted stent.The knot is tightened down enough to collapse the stent lumen, indicating a descent amount of force was applied to the catheter when trying to remove it.Per the ifu, ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered¿.Cook could not complete a review of the device history record (dhr) or complaint history on the complaint device lot due to lot information was not provided by the user facility.The instructions for use (ifu) lists the following precautions: complications of ureteral stent placement are documented in literature.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.The sof-flex, lse sof-flex, and sof-flex aq stents must not remain indwelling more than six months.These stents are not intended for permanent dwelling.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.A pregnant patient must be closely monitored for possible stent encrustation due to calcium supplements.Improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at point of stress after a prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested.Individual variations of interaction between stents and urinary system are unpredictable.Periodic evaluation via cystoscope, radiographic or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage.A definitive cause of why the stent became knotted could not be determined.Knotting is a known hazard of multi-length ureteral stents.Measures have been initiated to address this issue.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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.

Event Description

No new event information to report.

Event Description

No additional information received since initial report sent.

Manufacturer Narrative

During secondary review it was noted that the drop downs were inadvertently checked off incorrectly.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.

Event Description

Additional information received on 20dec2018.Male patient born in 1963.The aforementioned dj catheter was inserted during a surgical procedure for ureteral calculus.The subsequent attempt to remove a dj catheter in china on 31oct2018 failed because a kink had formed in the area of the proximal curling of the dj catheter which prevented extraction of the dj catheter.The impacted dj catheter had to be removed during an additional surgical procedure.

Manufacturer Narrative

Based on new information received on 20dec2018.Patient and device codes.

Event Description

Additional information was received on (b)(6) 2019.Based upon the information provided, the patient demographics have been changed/corrected.As reported, the patient is a 48-year-old, male, weighing 75 kilograms.As reported, during a ureteroscopic stone treatment in the upper urinary tract performed on (b)(6) 2018, the dj-stent was placed at the end of the intervention after the ureteroscopic stone treatment.There were no peculiarities of the patient's anatomy.The hydrophilic coating was activated in a sterile bath with sterile nac1 0.9% for >1 minute before insertion.According to the reporter, stent extraction 9 days later (b)(6) 2018) was not possible, because there was a knot in the proximal loop of the stent.The dj-stent had to be removed in a secondary operation on (b)(6) 2018 because of the knot in the stent.The procedure reported as nephrostomy tube, percutaneous nephroscopy and repeated retrograde approach.Patient's status was reported as "alive".

Manufacturer Narrative

Concomitant products: storz semirigid ureteroscope, telebrix contrast medium.The investigation remains in progress.A follow up report will be submitted should additional relevant information be received or upon completion of the investigation.

• Brand Name: KWART RETRO-INJECT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8164907
• MDR Text Key: 130502330
• Report Number: 1820334-2018-03683
• Device Sequence Number: 1
• Product Code: FAD
• 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,Followup,Followup,Followup
• Report Date: 03/11/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 003600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 11/30/2018; 12/20/2018; 01/31/2019; 03/04/2019
• Supplement Dates FDA Received: 12/20/2018; 01/15/2019; 02/05/2019; 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 75