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

Model Number	G53711
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
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, when attempting to place a guide wire inside the universa soft ureteral stent during an unknown procedure, the stent was broken.They had to "replace the client for a new product." according to the initial reported, there were no adverse effects to the patient due to this occurrence.Additional patient and event information has been requested.At this time, no further information is known.A follow up report will be submitted if additional details requested are received.
Event or Problem Description
No new patient information since the last report was submitted.
Additional Manufacturer Narrative
It was reported a stent from a universa soft ureteral stent set was noted to be broken when they first went place it on wire guide for placement.The tether had been removed by the physician.They switched to a new stent to complete the procedure.The complaint device was not returned, however a picture of the stent was supplied.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.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.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: the tether should be removed if the stent is to remain indwelling longer than 14 days.The complaint device was not returned.A photo was provided that shows a longitudinal split in the stent originating at a side port at one end of the device.The tether was reported to have been removed and would have been originally attached to the last side port on the proximal end of the stent.Its possible the stent was inadvertently damaged removing the tether.Based on the photo of the complaint device the split in the stent was confirmed and possibly caused inadvertently removing the tether.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.
Additional Manufacturer Narrative
Additional information: b5.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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 received on 02mar2020: the tether was removed as normal.One complaint device was confirmed.The device did not make patient contact.The indication for placing the stent was percutaneous nephrostomy.When they opened the box to use they realized the stent was broken.The procedure was completed using another new cook stent.

• 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: 9756170
• Report Number: 1820334-2020-00462
• Device Sequence Number: 2787210
• Product Code: FAD
• UDI-Device Identifier: 00827002537118
• UDI-Public: (01)00827002537118(17)210516(10)8888935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 05/16/2021
• Device Model Number: G53711
• Device Catalogue Number: US-726
• Device Lot Number: 8888935
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/02/2020; 04/13/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/23/2020; 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1