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

Model Number	G23407
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility reported the scrub tech noticed that the tapered end of the universa firm ureteral stent was crimped shut before use.As reported, this device was not used.The device did not make patient contact.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a visual inspection, dimensional verification, functional testing, a review of complaint history, the device history record, review of the instructions for use, quality control data and specifications.One open package labeled rpn ufh-626-rt1, lot 7711975 was received.Only the stent (partial device) was returned.The tether has been pulled out of the stent.The tip of the distal coil was smashed flat and could not be wired using an hsf-38-50c wire guide.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record showed there were no non-conformances associated with this complaint device lot number.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against the complaint device lot number 7711975.Based on the provided information and physical analysis it is likely the device damage is related to shipment of the product.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 6864941
• Report Number: 1820334-2017-02965
• Device Sequence Number: 18996678
• Product Code: FAD
• UDI-Device Identifier: 10827002234076
• UDI-Public: (01)10827002234076(17)200228(10)7711975
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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 Model Number: G23407
• Device Catalogue Number: UFH-628-RT1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1