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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that a universa firm ureteral stent set was "cut off" during an unspecified urology procedure.After cutting the suture string, the user noted that a small of piece or the distal portion of the stent was in their hand, while the larger portion of the stent was in the patient.A final x-ray was taken for confirmation.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

E1- customer (person): phone = (b)(6).E3- occupation: administration assistant.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B5: additional information received 27nov2023.D10: concomitant products.Correction: h6 (annex e and annex f).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

Additional information received 27nov2023: the stent was being place in the urethra for a left vuj obstruction when the stent split.A wire guide was used while placing the stent.The tether was removed after the stent was implanted.The stent was monitored by using an image intensifier and the stent was only in place a few minutes before the separation occurred.Once the device separated, the user "grabbed" the smaller fragment and removed it through the cystoscope.Only the smaller fragment was removed.After the fragment was removed, they ensured the child was well and reported the incident.

Manufacturer Narrative

H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.

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, unavailable, or unchanged.Event summary: it was reported that a universa firm ureteral stent set was "cut off" during an unspecified urology procedure.The stent was being placed in the urethra for a left vuj (vesico-ureteric junction) obstruction when the stent split.A wire guide was used while placing the stent.The tether was removed after the stent was implanted.The stent was monitored by using an image intensifier and the stent was only in place a few minutes before the separation occurred.Once the device separated, the user "grabbed" the smaller fragment and removed it through the cystoscope.Only the smaller fragment was removed.After the fragment was removed, they ensured the child was well and reported the incident.A final x-ray was taken for confirmation.Investigation ¿ evaluation.A document-based investigation was performed including a review of instructions for use (ifu) and quality control procedures, as well as a visual inspection of the device were conducted.One pigtail was returned to cook for evaluation without package or label for inspection.The appearance of the pigtail indicated the break to have occurred on the pigtail yet near the main body of the stent.There was no sideport tearing that can be seen in some cases where it is suspected that the tether removal and inadvertent user error cause fracture damage.Therefore, with only the broken segment of the stent and no additional procedural information it is unclear how the stent became fragmented.Additionally, 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.However, cook was unable to complete a review of the device history record (dhr) as the lot number of the device was unknown.A historic complaint search by lot was 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_uss_rev5] ¿universa firm ureteral stents and stent sets¿ contains the following information related to the reported failure mode.¿precautions ¿ the tether should be removed if the stent is to remain indwelling longer than 14 days.¿ ¿how supplied ¿ upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, the cause of the break was not able to be determined.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.

Event Description

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

• Brand Name: UNIVERSA FIRM 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: 18181159
• MDR Text Key: 328625632
• Report Number: 1820334-2023-01601
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2024

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 Model Number: N/A
• Device Catalogue Number: UFH-624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/27/2023; 12/20/2023; 02/13/2024
• Supplement Dates FDA Received: 12/05/2023; 01/11/2024; 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: AMPLATZ WIRE, TERUMO WIRE.
• Patient Age: 24 MO
• Patient Sex: Male