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

Model Number	4245020W
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Complaint conclusion: as reported, after opening the outer package of the aviator plus.014 5.0 x 20 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.One product was returned for analysis.A non-sterile packaging/pouch/box of an aviator plus.014 5.0 x 20 142cm, along with a 30g flushing needle inside a separated plastic tube was received for analysis inside a plastic bag.Per visual analysis, the aviator balloon was received out from its coiled protective tubing.Also, it was observed that the packaging outer box was ripped- opened at the labeled side (as expected), and the packaging inner pouch was found not sealed at the bottom of the pouch the way it should, as expected per ppe specification.Per microscopic analysis, the unsealed pouch was inspected under the vision system with a particular focus on the pouch bottom area looking for any seal pattern marks.None were observed.A product history record (phr) review of lot 82214871 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box compromised sterility - seal open¿ was confirmed via device analysis.However, the exact cause cannot be determined.According to microscopic analysis of the returned packaging, no seal pattern markings were present on the bottom portion of the pouch as expected.Therefore, it appears the reported events are related to the manufacturing process.According to the warnings in the instructions for use, ¿do not use if inner package is opened or damaged.¿ the product analysis suggests that the event experienced by the customer may be associated to the manufacturing process; therefore, a risk assessment has been initiated for further investigation.

• Brand Name: AVIATOR PLUS .014 5.0X20 142CM
• Common Device Name: 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
• Report Number: 9616099-2021-04997
• Device Sequence Number: 19858314
• Product Code: LIT
• UDI-Device Identifier: 20705032005828
• UDI-Public: (01)20705032005828(17)240229(10)82214871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK BALLOON
• Patient Sex: Unknown