MAUDE Adverse Event Report: WILLIAM COOK EUROPE FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT; WLQ BALLOON STENT

Model Number	G56968
Medical Device Problem Codes	Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: when the stent was placed in the patient, it looked as though the stent had slipped off the balloon.This caused the physician to worry that the stent would be malpositioned.The product was removed from the patient and the procedure was completed with a competitor's product.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).(b)(4).Summary of investigational findings: no product was returned and the image provided did not show the complaint device.Therefore, it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us concerning "the stent had slipped off the balloon." no evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the device did not perform as intended.Cook medical will continue to monitor for similar events.

• Brand Name: FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT
• Common Device Name: WLQ BALLOON STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 6645935
• Report Number: 3002808486-2017-01286
• Device Sequence Number: 1149596
• Product Code: NIN
• UDI-Device Identifier: 10827002569680
• UDI-Public: (01)10827002569680(17)181106(10)E3383656
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: G56968
• Device Catalogue Number: FORX414-14-135-5-16
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/24/2017
• Device Age: 18 MO
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1