MAUDE Adverse Event Report: COOK INC C-FLEX MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
A (b)(6) patient underwent pyloplasty.The distal pigtail had memory loss causing the stent to migrate up the right ureter.The stent was removed with no replacement required.The stent was insitu for 6 weeks.During the original placement of the stent, the surgeon was happy with the placement of both pigtails.The patient did not require additional procedures due to this event.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of dimensional verification, complaint history, device history record, documentation, manufacturing instructions, drawing, specifications, trends, and quality control data was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The (ifu) does not contain information regarding the failure mode.Review of the device history record found 4 other nonconformances associated with the complaint device lot number.The non-conformances were all for foreign matter.No other reported complaints were found for this lot number.Based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6122579
• Report Number: 1820334-2016-01329
• Device Sequence Number: 1075863
• Product Code: FAD
• UDI-Device Identifier: 00827002173064
• UDI-Public: (01)00827002173064(17)181215(10)6455330
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2017

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: 11/16/2016
• Supplement Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 11/22/2016
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR