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

Catalog Number 133626

Device Problem Material Separation (1562)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

E1: customer (person) postal code = (b)(6).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

As reported, during removal of a 'filiform double pigtail ureteral stent', a portion of the stent separated in the patient.The device section was removed with a stent grasper during the same procedure.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.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: as reported, during removal of a 'filiform double pigtail ureteral stent', a portion of the stent separated in the patient.The device section was removed with a stent grasper during the same procedure.No adverse effects have been reported due to this incident.Reviews of the complaint history, instructions for use (ifu), and quality control procedures for the device were conducted during the investigation.A device failure analysis was unable to be conducted at cook as the device was not returned for inspection.It appears that the customer has been unable to locate the complaint device for return.However, 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.Cook was unable to complete a review of the device history record (dhr) for the device lot since the lot number was unknown.A historic complaint search for other complaints for stents from the same lot number was also unable to be conducted for the same reason.The information provided upon review of complaint file and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house were nonconforming.Cook also reviewed product labeling.The product ifu, [t_dpss_rev3] "filiform double pigtail stent" contains the following information related to 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." "how supplied: upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no device return, and the results of the investigation, the cause of the break was not able to be determined for this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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: 18335956
• MDR Text Key: 331061609
• Report Number: 1820334-2023-01704
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 133626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: STORZ STENT GRASPER