MAUDE Adverse Event Report: COOK INC C-FLEX MULTI-LENGTH 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	05/22/2017
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 c-flex multi-length 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.
Additional Manufacturer Narrative
Investigation/evaluation: a review of the complaint history, device history record, documentation, specifications, and visual inspection of the returned device was conducted during the investigation.One stent was returned for investigation.The stent was received in two pieces.The tether was still attached to the proximal coil.The stent coil has been severed from the stent body where the coil starts to curve.The point of separation appears pinched and cut at an angle.The tether was frayed and separated between the knot and the end of the of the proximal coil; several areas along the tether appear stressed indicating force was applied to the tether during removal.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 observed one non-conformance for component displaced in pack.There were no other reported complaints associated with lot number 7597754.Based on the information provided and the results of the investigation, the root cause is likely due to the handling of the product.However, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.Appropriate personnel have been notified of this event.

• Brand Name: C-FLEX MULTI-LENGTH URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6653820
• Report Number: 1820334-2017-01310
• Device Sequence Number: 1306511
• Product Code: FAD
• UDI-Device Identifier: 00827002173064
• UDI-Public: (01)00827002173064(17)200117(10)7597754
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/04/2017

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: 036300-T-8-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1