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

Model Number	G49942
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported, during a ureterorenoscopy using a universa soft ureteral stent set, the user opened the package to discover there was a fissure on the front end of the stent.The physician sued another new same type device to complete the procedure.According to the initial reported, there were no adverse effects to the patient due to this occurrence.Additional information has been requested.A follow up report will be submitted if additional details requested are received.
Additional Manufacturer Narrative
Cook was informed on (b)(6) 2020 of an event involving a universa soft ureteral stent set.The user opened the package and found the front end of the stent had a fissure.To correct the issue, a second stent set was opened to complete the procedure.There was no harm to the patient as a result of the event.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, specifications, and quality control data.The complainant returned one open package containing a universa soft stent for investigation.Visual examination confirmed stent only was returned in prior to use condition.Remaining set components were not returned.The tether was not returned with the stent.Closer examination revealed the tear originated at the last side port measuring approximately 1cm long.Tear stops 1mm from the end of the coil end.No other damage found on the stent.Stent was damaged during tether removal.A review of the device history record (dhr) 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.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description: a braided or monofilament tether for repositioning and removal of the device is located on the proximal pigatil of the stent.Precautions: the tether should be removed if the stent is to remain indwelling longer than 14 days.How supplied: upon removal from the package, inspect the product to ensure no damage has occurred.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.Evidence presented by the returned complaint device found the tear in the stent material consistent with the location of the tether which was not returned.The evidence suggests the catheter material was torn when the tether was removed.Based on the evidence presented by the sample, this event has been contributed to rigorous handling of the device in a clinical setting.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.
Event or Problem Description
No new patient or event information since the last report was submitted.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9883417
• Report Number: 1820334-2020-00690
• Device Sequence Number: 2784711
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)221018(10)10092223
• Combination Product (Y/N): N
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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: 10/18/2022
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Device Lot Number: 10092223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1