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

Catalog Number FORX4-14-135-7-16

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Common name: (b)(6).Similar to device under pma/510(k) p100028.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the balloon burst when it was inflated to 10 atm.Patient outcome: unknown.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the investigation is based on the event description only.It was reported that the balloon burst, when inflated to 10atm.Balloon and stent were removed and another device was used to complete the procedure.No product was returned and no imaging received and based on the information provided it would be inappropriate to speculate at what may or may not have caused the balloon to burst, but it is noted that the balloon was inflated to 10atm.According to the instructions for use the rated burst pressure is 12, but the recommended expansion pressure is 8atm for a nominal stent id of 7.0mm and it is stated under the balloon expansion/stent deployment section to inflate the balloon to the recommended expansion pressure.Also, it is noted that the stent was removed with the balloon without any reported effect to the patient and therefore it is assumed that the stent was not expanded to an extent to release from the balloon.No evidence to suggest that 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.

Manufacturer Narrative

Manufacturer ref#: (b)(4).Investigation is still in progress.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

Additional information received 09jan2020: "doctor told to me that he just inflated to 10 atm then the balloon was bursted, so he removed the bursted balloon and changed another new one to complete this case.".

• Brand Name: FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9542623
• MDR Text Key: 184467653
• Report Number: 3002808486-2019-01984
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002455129
• UDI-Public: (01)10827002455129(17)210611(10)E3734959
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Catalogue Number: FORX4-14-135-7-16
• Device Lot Number: E3734959
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1