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

Model Number G56959

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Common device name: nin, stent, renal.Ame and address for importer site: (b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: the stent was accidentally removed from the delivery catheter during prep.The tech did not realize that the stent had not remained on the delivery catheter until they attempted to place it in the renal artery.The stent was then found on the prep table.The procedure was successfully completed with another device.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.(b)(4).Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable.(b)(4).Summary of investigational findings: no product was returned and therefore it would be inappropriate to speculate at what may or may not have caused the stent to accidentally slip the balloon prior to use.Ifu, preparation: remove the formula 414 rx renal balloon-expandable stent system from the package, remove protective sleeve from the distal tip of the catheter, and inspect the stent to ensure it has not been damaged.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.Cook medical will continue to monitor for similar events.

Event Description

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

Manufacturer Narrative

Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer ref# (b)(4).G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.Summary of investigational findings: no product was returned and therefore it would be inappropriate to speculate at what may or may not have caused the stent to accidentally slip the balloon prior to use.Ifu, preparation: remove the formula 414 rx renal balloon-expandable stent system from the package, remove protective sleeve from the distal tip of the catheter, and inspect the stent to ensure it has not been damaged.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that it did not perform as intended.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.

• Brand Name: FORMULA 414 RX RENAL BALLOON EXPANDABLE STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 7326364
• MDR Text Key: 102212618
• Report Number: 3002808486-2018-00339
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002569598
• UDI-Public: (01)10827002569598(17)180609(10)E3336109
• Combination Product (y/n): N
• PMA/PMN Number: P100028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2018
• Device Model Number: G56959
• Device Catalogue Number: FORX414-14-80-5-16
• Device Lot Number: E3336109
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/26/2018
• Device Age: 32 MO
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1