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

Model Number	G23374
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: asc manager.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 an unknown procedure using a universa soft ureteral stent, the end of the stent was split.The split was noticed immediately after the device was removed from the package.Another same type device was opened and used to successfully complete the procedure.According to the initial reporter, there was no patient contact therefore no adverse effects were reported due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation: additional information: b5.Description of event: it was reported the end of a stent for universa soft ureteral stent sets (part number ush-624-rt1, lot 10117729) was spit.This was noticed by the facility immediately upon taking the device out of the package.The facility opened up a new stent set (part number ush-624-rt1) to complete the intended procedure successfully.It not known if the tether had been removed or which end of the stent was split.The complaint device was not available for return and no photos of the device were available.Device master record (dmr) review: in response to this incident, cook completed a review of the product dmr cook has concluded inspection activities are in place to ensure no damage to the stent prior to distribution.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Instructions for use (ifu) the stent set was supplied with the device was reviewed and the following precaution is included: the tether should be removed if the stent is to remain indwelling longer that 14 days.Device history record (dhr) review: in response to this incident, cook completed a review of the dhr for the complaint lot and no non conformances were found to be recorded.Additional complaints: a search of the complaint database found no additional complaints reported for lot.Device failure analysis: the complaint device was not returned and there is no remaining stock of the reported lot in the cook north america distribution center so the a device failure analysis of the complaint product or a sample from the same lot could not be carried out.A similar report with a failure mode description of a slit at the tip of the stent with a device return was attributed to the tether tearing the stent.Conclusion the complaint device was not returned so a device failure analysis could not be carried out.A review of the dhr did not identify any related anomalies.There have been no other complaints reported for the same lot at the time of this investigation.During final inspection of the product there is a 100% inspection of the stent tips.The cause of the complaint could not be established.It is possible that the tether split the stent based on what was found on a similar complaint report.Based on the available information, cook has concluded that the complaint device did not contribute to this incident.The risk analysis for this failure mode was reviewed and no additional escalation was required.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.
Event or Problem Description
Additional information provided 02apr2020: it is not known if the tether was removed from the device.There are no photos available of the complaint device.It is unknown which end of the stent was split.

• 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: 9670654
• Report Number: 1820334-2020-00287
• Device Sequence Number: 19561390
• Product Code: FAD
• UDI-Device Identifier: 10827002233741
• UDI-Public: (01)10827002233741(17)221030(10)10117729
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 10/30/2022
• Device Model Number: G23374
• Device Catalogue Number: USH-624-RT1
• Device Lot Number: 10117729
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1