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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 customer reported that the universa soft ureteral stent set was chosen to perform an endoscopic ureterolithotricia procedure.However, the catheter wall was found to be broken.The issue was discovered prior to use, and no adverse events occurred as a result of the reported condition.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, instructions for use (ifu), specifications, and a visual inspection of the returned device.One universa soft ureteral stent set was received in an opened package labeled rpn ush-524, lot 6207102.The stent, positioner, pigtail straightener and the wire guide were returned.The tether was not returned.The stent was torn starting at the 1st side port on the proximal end and stopping within 5mm from the proximal end of the coil.No manufacturing anomalies were observed with the returned product.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 identified during the manufacturing process.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received against this complaint device lot number 7299024.Based on the evidence presented by the sample and the physical analysis, this stent has been damaged during tether removal.A definitive root cause may be related to product use and handling as confirmed by condition of the returned device.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 SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6733648
• Report Number: 1820334-2017-01836
• Device Sequence Number: 18995855
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)190923(10)7299024
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: USH-626
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1