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

Model Number G49866

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problems Laceration(s) (1946); No Code Available (3191)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported on (b)(6) 2018, the (b)(6) male patient with nephrolithiasis underwent a percutaneous nephrolithotomy (pcnl) procedure.An open-end ureteral catheter, g15944, was used.During the cannulation of the meatus, the doctor reports a rupture of the open end catheter.The damaged open-end ureteral catheter was removed and the procedure continued with another open-end ureteral catheter.After extracting the stone, the universa firm ureteral stent set wire guide was introduced retrograde, leaving the tip in the renal access.The doctor decided to place the dj anterogradely.Doctor pulled the wire guide and perceived high resistance, so the assistant surgeon pulled out the wire guide from the urethra.The guidewire was extracted with the ptfe coating completely unraveled, causing a urethral laceration.The laceration was sutured.Additional information has been requested regarding the reported failure mode and patient outcome but has not yet been received.As reported, the device is not being returned.A request has been made for photos and imaging to assist in the investigation.

Event Description

There has been no new information received since the last report was submitted.

Manufacturer Narrative

Investigation: evaluation: the complaint device was not returned for an evaluation and no photograph or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.No similar product from the same lot is available for investigation.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.The device history record was reviewed noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed this is the only complaint associated with the complaint device lot number: 8264899.The instructions for use (ifu) provides the following relevant information: warnings: 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.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.Cautions: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.The customer mentioned that resistance was met when withdrawing the wire guide.This may be due to the unraveling of the wire guide changing the shape of the device to be less smooth and cylindrical.This would also explain the reported urethral laceration in the patient.Without more information however, this cannot be confirmed.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.A definitive conclusion was unable to be made.Previous investigations have shown that wire guides commonly unravel when withdrawn through a needle or withdrawn when the tip is stuck.However, since no needle was apparently used, another factor may have contributed.Potentially tortuous patient anatomy may have contributed to the failure since the patient was undergoing a procedure to remove kidney stones.Without more information however, a main cause of failure cannot be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.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: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7657870
• MDR Text Key: 112995182
• Report Number: 1820334-2018-02043
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002498662
• UDI-Public: (01)00827002498662(17)201003(10)8264899
• Combination Product (y/n): N
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

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 Expiration Date: 10/03/2020
• Device Model Number: G49866
• Device Catalogue Number: UFH-526
• Device Lot Number: 8264899
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYSTOSCOPE, CATHETER; CYSTOSCOPE, CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR