MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 8X4 80CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4158040S

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but has not yet been received. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the sterile pouch of an 8mm x 4mm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter was never sealed at the bottom. There was no reported patient injury. The pouch was not previously opened. The packaging had not been damaged. The package was not opened for a patient and it was noticed before ever needing to be used. The device is expected to be returned for evaluation. Images were available for review. Image 1 was reviewed. Upon review, it appears the seal is missing from an unknown inner package. Image 2 was reviewed. Upon review, this appears to be an image of what the seal is supposed to look like, or possibly showing the other end of the packaging is as it should be. Image 3 was reviewed. Upon review, this is a photo of a powerflex extreme label with the device in its original packaging.

• Brand Name: POWERFLEX EXTREME 8X4 80CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9972587
• MDR Text Key: 200516892
• Report Number: 9616099-2020-03652
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4158040S
• Device Catalogue Number: 4158040S
• Device Lot Number: 82180077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial