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

Model Number	G49942
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient code: no consequences or impact to patient.Device code: crack is not labeled.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 the physician opened the universa soft ureteral stent set and found there was a fissure in the end of stent.Thus, the physician used another new ush-626 stent to finish this medical procedure.Additional information was provided that the "fissure" was found prior to contact once package was opened.Stent was checked and fissure found without another device or equipment in use.
Event or Problem Description
There has been no additional information received since the last report was submitted.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, and quality control data.One opened package labeled rpn ush-626 with label lot number 8972546 was received.Uss-626-aq and stppn-070046-rm positioner were also returned.Visual examination of the returned positioner revealed no manufacturing anomalies on the positioner.The stent was missing the tether and the tether was not returned.The proximal stent coil is torn starting at the first sideport and extending through the end of the coil.The device history record review showed there were no non-conformances associated with the reported failure.A search of complaint records revealed this is the only complaint for the tether breaking associated with lot number 8972546.A review of manufacturing documents identified this product is inspected before shipment.The device was returned without a tether attached (the tether was also not returned) and it was observed that there was a tear starting at the first side port closest to the proximal end of the stent.The tear extended to the end of the stent.The first side port is where the tether is attached to the stent.The manner in which the tether was removed could have contributed to the complaint.The possible cause of the complaint; the stent was damaged when the tether was removed.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor 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 SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7827150
• Report Number: 1820334-2018-02614
• Device Sequence Number: 11349863
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)210622(10)8972546
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: 06/22/2021
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Device Lot Number: 8972546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/27/2018
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 67