MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 5.0X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4245020W

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2021

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 the device has not yet been received. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after opening the outer package of the aviator plus. 014 5. 0x20 142cm, it was found that the inner package of the balloon product was not well sealed. The product was stored in the hospital equipment cabinet, and the barcode on the outer packaging is removed and pasted on the patient surgical information record file when used. In this case, there was no trace of the barcode that had been removed before the outer packaging was opened. There was no reported patient injury. The balloon was replaced with another balloon. The intended procedure was a balloon dilation of pulmonary hypertension. The device was stored in the lab in a constant temperature and humidity equipment cabinet. The product will be returned for evaluation.

• Brand Name: AVIATOR PLUS .014 5.0X20 142CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12682972
• MDR Text Key: 279314365
• Report Number: 9616099-2021-04997
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4245020W
• Device Catalogue Number: 4245020W
• Device Lot Number: 82214871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial