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

Model Number	G49874
Medical Device Problem Codes	Crack (1135); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
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 has been reported that during a left-side percutaneous nephrolithotomy (pcnl) procedure involving a (b)(6) year-old male patient, a crack was detected in the pigtail end of the stent from a universa firm ureteral stent set.The complaint device was being advanced to the left ureter, when the crack was observed through the nephroscope.The device was then removed and replaced with a similar device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Update 05aug2019: the user cut the tether during the procedure.
Additional Manufacturer Narrative
Additional information: investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Inspection of the returned device noted the device was returned with a tear in the proximal coil.The tether was not returned with the stent.The tear started at the first side port and continued vertically along the coil for 6 mm.Under magnification, striations in the material fibers were observed on the torn edge.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: tether should be removed if stent is to remain indwelling longer than 14 days.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The returned device was found to have a tear starting near the first side port and continued toward the proximal tip.This location of the tear is also where the tether would have been attached, but it was not returned with the device for evaluation.It is likely that the device was manufactured within specification, but the damage to the stent caused it to be non-functional.It is possible the cause for the tear in the stent was that the device was inadvertently damaged when removing the tether, or during subsequent handling, but there is no information related to device damage from handling.The most probable cause for the stent damage could not be established.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.

• 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: 8817919
• Report Number: 1820334-2019-01768
• Device Sequence Number: 2838581
• Product Code: FAD
• UDI-Device Identifier: 00827002498747
• UDI-Public: (01)00827002498747(17)220326(10)9621393
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 03/26/2022
• Device Model Number: G49874
• Device Catalogue Number: UFH-626
• Device Lot Number: 9621393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 120