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

Catalog Number 133626

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/22/2020

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 was reported, during the removal of a filiform double pigtail ureteral stent placed in (b)(6) 2020, the one pigtail portion and a 3-5 cm portion of the device broke off and remained between the renal pelvis and the joint.The stent was indwelling for two months and placed after laser lithotripsy.The patient underwent outpatient cystoscopy for the removal.The urologist used the cystoscope and forceps to remove the stent, but at the end of the procedure noted the device separation.The patient will undergo percutaneous nephrolithotomy (pcnl) surgery for removal of the remaining device segment.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence additional information has been requested regarding the patient's outcome and additional procedure required.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: it was reported, during the removal of a filiform double pigtail ureteral stent placed in (b)(6) 2020, the one pigtail portion and a 3-5 cm portion of the device broke off and remained between the renal pelvis and the joint.The stent was indwelling for two months and placed after laser lithotripsy.The patient underwent outpatient cystoscopy for the removal.The urologist used the cystoscope and forceps to remove the stent, but at the end of the procedure noted the device separation.The patient will undergo percutaneous nephrolithotomy (pcnl) surgery for removal of the remaining device segment.No additional patient consequences were reported.Additional information was received 29oct2020 advising the procedure to remove the remaining portion of the stent has not yet been carried out due to the covid-19 pandemic.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record (dhr), drawing, the instructions for use (ifu), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.A review of our distribution center records found there was no remaining stock from the reported lot, so a sample from the reported lot could not be reviewed.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user.Precuations improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.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.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.Per the ifu: ¿do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.¿ there was no information regarding, how the stent was initially prepared, or if there was difficulty during placement.Difficulty or resistance with placement and removal could potentially cause the user to manipulate the device.This varying manipulation could contribute to the separation.Per the ifu: ¿improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after 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 21.0fr are suggested.¿ there was no information regarding the initial placement of the stent.It is possible that acute bending and/or overstressing during placement contributed to the failure of device.However, not enough information has been provided to determine that.Additionally, the use of the forceps for the removal procedure could have contributed to the weakening and separation of the stent.Per the ifu: ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ no information was provided regarding how the device was prepared prior to insertion.Based on the available information cook was unable to rule out any possible causes for this event such as product handling, medical procedure, device failure, or manufacturing related causes.Cook has concluded a cause for the event could not be established.The risk analysis for this failure mode was reviewed, and it was determined that no actions are required.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: 10721712
• MDR Text Key: 212716563
• Report Number: 1820334-2020-01923
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151465
• UDI-Public: (01)10827002151465(17)230228(10)13018455
• 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: 01/25/2021

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: 02/28/2023
• Device Catalogue Number: 133626
• Device Lot Number: 13018455
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MULTI-PURPOSE STEEL FORCEPS; STORZ CYSTOSCOPE
• Patient Outcome(s): Required Intervention