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

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	04/05/2017
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 customer reported that the tip of the wire guide of a universa soft ureteral stent set was found broken when the package was opened.The device did not come in contact with the patient.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information has been provided at this time.
Additional Manufacturer Narrative
Investigation ¿ evaluation: one used and damaged fixed core wire guide from a universa soft ureteral stent was returned for evaluation.The wire guide is elongated at the distal end.The core wire measures 144.2 cm.The weld is missing at the distal end.The safety wire is exposed.Approximately 270 cm of elongated coil wire is past the distal end of the core wire.The coil wire starts to elongate at 123.0 cm from the proximal end.A kink is noted 115.5 cm from the proximal end.No damage is noted to the coating.Based on the information provided, the root cause of the damaged wire guide is unable to be determined.A review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.A review of the device history record for this product revealed no non-conformances during the manufacturing process.There were no indications that this device was no manufactured to specification.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: 6584891
• Report Number: 1820334-2017-01079
• Device Sequence Number: 13609014
• Product Code: FAD
• UDI-Device Identifier: 00827002499454
• UDI-Public: (01)00827002499454(17)181130(10)6415518
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2017

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: N/A
• Device Catalogue Number: USH-600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1