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

Catalog Number 133624

Device Problem Material Disintegration (1177)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  Injury  

Event Description

As reported, the user was removing a 'filiform double pigtail ureteral stent' from a patient, after being indwelling ~9 months.During the removal, the stent began to 'disintegrate' while inside the patient.The user was able to successfully retrieve all the stent fragments.The stent was being removed as a scheduled stent removal and exchange procedure.The stent was not monitored during the indwell period.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

G4: pma/510(k) number = preamendment.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: a representative of (b)(6) hospital informed cook on 13jun2023 regarding an issue with a filiform double pigtail ureteral stent (rpn: 133624, lot 13206354).The user was removing the stent from a patient during a left ureteric stent removal/exchange procedure, after being indwelling for approximately 9 months.During the removal, the stent began to "disintegrate" while inside the patient.The user was able to successfully retrieve all the stent fragments.The stent was not monitored during the indwelling period.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.Visual inspection of the returned complaint device was also conducted.One used filiform double pigtail ureteral stent was returned for investigation.The device was returned in multiple pieces; all points of separation were even and clean; the stent was encrusted with a dark biomatter.A document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A search of the device history record found no related non-conformances reported for lot 13206354.Additionally, a complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Because there are 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 field.No evidence was found suggesting the device as manufactured out of specification.Cook also reviewed product labeling.The ifu [t_dpss_rev3; 'filiform double pigtail stent'] supplied with the device states the following in consideration of the reported failure mode: - ¿precautions: do not force set components during placement, replacement, or removal.Carefully remove the set components if any resistance is encountered.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.Angulation of the stent should be avoided.Use of a 0-degree scope lens is recommended.Scopes larger than 21.0 french are suggested." ¿a pregnant patient must be more closely monitored for possible stent encrustation due to calcium supplements.¿individual variations of interaction between stents and the urinary system are unpredictable.¿ ¿periodic evaluation cystoscopic, radiographic, or ultrasonic means is suggested.¿ - ¿how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from the package, inspect the product to ensure no damage has occurred.¿ based upon the available information and results of the investigation, a definitive cause of the stent separation could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17209425
• MDR Text Key: 317944517
• Report Number: 1820334-2023-00821
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002151458
• UDI-Public: (01)10827002151458(17)230521(10)13206354
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Catalogue Number: 133624
• Device Lot Number: 13206354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2020
• 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
• Treatment: CYSTOSCOPE, STENT GRASPER, GUIDEWIRE
• Patient Outcome(s): Required Intervention