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

Model Number G56968

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Investigation is still in progress.

Event 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.

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
• Type of Device: WLQ BALLOON STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: thomas hessner kirk ; sandet 6; bjaeverskov DK-46-32 ; DA DK-4632 ; 56868686
• MDR Report Key: 6645935
• MDR Text Key: 77938502
• Report Number: 3002808486-2017-01286
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002569680
• UDI-Public: (01)10827002569680(17)181106(10)E3383656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G56968
• Device Catalogue Number: FORX414-14-135-5-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/24/2017
• Device Age: 18 MO
• Date Manufacturer Received: 05/31/2017
• Date Device Manufactured: 11/06/2015
• 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