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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event 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.

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
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6122579
• MDR Text Key: 60763338
• Report Number: 1820334-2016-01329
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002173064
• UDI-Public: (01)00827002173064(17)181215(10)6455330
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 036300-T-8-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 9 YR