MAUDE Adverse Event Report: WILLIAM COOK EUROPE FORMULA 414 RX BALLOON-EXPANDABLE STENT

Catalog Number FOVX414-14-135-4-16

Device Problem Material Separation (1562)

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

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Common device name: nin ¿ renal balloon-expandable stent.Similar to device under pma/510(k) p100028.Investigation is still in progress.

Event Description

Description of event according to initial reporter: stent came loose together with the covering protective tube and could no longer be used.Prior to use the protection tube of the stent had been removed.After getting the delivery system to the right place physician wanted to inflate the balloon and expand the stent.By doing this he realised that the stent was not there and the balloon inflated without a stent.Not knowing where the stent had been lost and being afraid it might be somewhere intracorporal physician searched all the vascular way from entry point to stenting area via x-ray.Just by accident a nurse found the stent still sticking in the protection tube which has been put beside.The stent was showing out just a few mm out of the tube.Then a second stent was opened and placed successfully.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

Manufacturer ref#: (b)(4).After investigation the event for this pr# is no longer reportable.Summary of investigational findings: the investigation was based on the event description and the returned device.It was reported that the stent came loose with the protection tube and that it was discovered during inflation of the balloon.The complete device was returned - the protection sleeve had slipped the balloon and the stent was still inside the sleeve.The balloon catheter appeared used and biological matter was present.An investigation of every component revealed no non-conformances and the stent did not stick inside the protection sleeve, but could be removed only by shaking.The exact reason for the stent to slip the balloon when removing the protection sleeve cannot be determined, but according to ifu the stent must be inspected after removing the protection sleeve to ensure it has not been damaged or has slipped as in this case.No evidence to suggest the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FORMULA 414 RX BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9004111
• MDR Text Key: 182985337
• Report Number: 3002808486-2019-01464
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002037639
• UDI-Public: (01)10827002037639(17)191025(10)E3510096
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: FOVX414-14-135-4-16
• Device Lot Number: E3510096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1