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

Catalog Number 003700

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 11/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: non healthcare professional.Pma/510(k) # 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 a ureteroscopy stone removal.After an unknown period of time, the provider attempted to remove the kwart retro-inject ureteral stent.The stent could not be extracted due to a knot that had formed in the area of the proximal catheter loops.The patient required an unknown additional operative intervention to remove the device.Patient outcome post-procedure is unknown at this time.

Manufacturer Narrative

Additional information: concomitant medical products.The complaint device was received for analysis on 03jan018.However, the complaint number referenced on the returned packaging was determined to be incorrect.On (b)(6) 2018, a dimensional verification of the device confirmed this product is the complaint device associated with this event.The investigation is in progress.A follow up report will be submitted should additional relevant information be received or upon completion of the investigation.

Event Description

No new event information received since last report was submitted.

Event Description

No additional information received since initial mdr sent.

Manufacturer Narrative

During secondary review it was noted that the drop downs in b1 and h1 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 if a malfunction occurred.

Manufacturer Narrative

The investigation is in progress.A follow up report will be submitted should additional relevant information be received or upon completion of the investigation.

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 55-year-old, male, weighing 69.5 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.According to the reporter, 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.A stent extraction attempt on (b)(6) 2018, (ca.2 months later) was not possible because there was a knot in the proximal loop of the stent.The whole dj-stent had to be removed in a secondary operation on (b)(6) 2018 because of the knot in the stent.Patient's status was reported as "alive".

Manufacturer Narrative

Based on new information received on (b)(6) 2018.Patient and device codes.

Event Description

Additional information received on (b)(6) 2018.Male patient born in 1970.The aforementioned dj catheter was inserted during an ureteroscopic stone removal.The subsequent attempt to remove a dj catheter on (b)(6)2018 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 on (b)(6) 2018.

Event Description

No new event information to report.

Manufacturer Narrative

A4: weight: 69500 grams.Investigation/evaluation: customer returned one used mlssf-070022-32-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.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.

• 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: 8165130
• MDR Text Key: 130495959
• Report Number: 1820334-2018-03682
• 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: 03/08/2019

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: 003700
• 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: 12/19/2018; 12/20/2018; 01/10/2019; 01/31/2019; 03/04/2019
• Supplement Dates FDA Received: 12/20/2018; 01/09/2019; 01/10/2019; 02/05/2019; 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TELEBRIX CONTRAST MEDIUM
• Patient Age: 55 YR
• Patient Weight: 69