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

Catalog Number FORX4-14-80-6-20

Device Problems Difficult to Insert (1316); Premature Activation (1484)

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

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Similar to device under 510(k) p100028.(b)(4).Summary of investigational findings: no product was returned and no imaging was provided, and based on very limited information provided the exact reason, why it "was difficult to go through with the second stent" cannot be determined.And also, it is not possible to comment on the distal portion being "crushed and released inside the sheath." there is no evidence to suggest product was not manufactured according to specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: the patient was being submitted to an angioplasty and after the catheterization of the left artery was difficult to go through with the second stent.Many attempts were realized to go through without success.Then the stent was removed and its distal portion was crushed and released inside the sheath.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.

• Brand Name: FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT
• Type of Device: WLQ BALLOON STENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 6334889
• MDR Text Key: 67938776
• Report Number: 3002808486-2017-00454
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002455020
• UDI-Public: (01)10827002455020(17)180717(10)E3347977
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FORX4-14-80-6-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2016
• Date Device Manufactured: 07/17/2015
• 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