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

Model Number	G23406
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k161236.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was initially reported, during a percutaneous removal of a universa firm ureteral stent, the stent migrated either up into the kidney or down into the bladder.It was difficult to remove the stent.There were similar complaints in five patients (patient reference (b)(6)).It was reported that the stent pigtails failed to hold the device in place.Further communication with the associated company representative noted the exact number of patients/cases was unknown.The customer reported two different lot numbers, but the quantity from each lot is unknown.The manufacturer inquired whether the stents were removed percutaneously or transurethrally , and the rep believes they were removed transurethrally.Although, this information is still being confirmed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A section of the device did not remain inside of the patient's body.The patient did not require any additional procedures due to the occurrence.Additional information regarding the patient and event details have been requested.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
Additional information received on 31jan2020: it was confirmed that there were 6 total complaints (b)(4) of stents migrating in patients, making removal more difficult.No other information was available.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a document based investigation was performed including a review of the instructions for use 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 the product was not made to specifications.A review of the device history record could not be carried out as the lot number is unknown.A search for additional complaints on the same lot could not be carried out as the lot number is unknown.The same customer has reported 5 other similar events occurring within a short time period of this one.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: caution: "periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage." the endoscopic placement instructions include using a baseline pyelogram, estimate the proper stent length; add 1 cm to that estimated ureteral measurement.Accurate measurement enhances drainage efficiency and patient comfort.Watch for the distal end of the stent at the ureterovesical junction.At that point, halt advancement of the stent.As an assistant removes the wire guide, hold the stent in position with the positioner.The stent pigtail will form spontaneously.Carefully remove the positioner from the cystoscope.A journal review found that breau and norman (the journal of urology, 2001, volume 166 issue 3, sep 2001 p890-893 (optimal prevention and management of proximal ureteral stent migration and remigration) identified in a evaluation of stent migration "proximal migration occurs when a stent is too short for the ureter.We recommend that ureteral length should be measured directly from an x-ray to select the optimal stent length.If it is necessary to continue stenting a ureter after migration has been detected, a longer stent should be placed." a complaint device failure analysis could not be carried out as the complaint device was not returned for this complaint.The information provided upon review of complaint file and quality control documents do 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 are nonconforming.A cause for the complaint could not be determined.Per the quality engineering risk assessment, no further action is warranted.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5.Corrected information: b1, h1.B1: adverse event/product problem: no product problem.H1: type of reportable event: there was no reportable event.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 or Problem Description
Additional information provided 09jan2020 clarifies that there were only two patients/cases involved (and not five as previously reported).These cases are reported in patient identifier (b)(6).

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9536311
• Report Number: 1820334-2019-03188
• Device Sequence Number: 3389505
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)220702(10)9853458
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2022
• Device Model Number: G23406
• Device Catalogue Number: UFH-626-RT1
• Device Lot Number: 9853458
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/09/2020; 02/07/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 01/10/2020; 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1