MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV AVIATOR PLUS .014 5.0X40 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number: (b)(6).The device was returned but the engineering report is pending.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A.014 5.0x40 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter ruptured at nominal pressure during use.There was no reported patient injury.The device will be returned for analysis.
Additional Manufacturer Narrative
The lesion was calcified but there was no vessel tortuosity.A peripheral interventional procedure had been performed.The access site was the femoral.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.The balloon catheter did not kink while being used.The procedure was completed with another device.Additional patient and procedural details were requested but were unknown.A.014 5.0x40 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter ruptured at nominal pressure during use.The procedure was completed with another device.There was no reported patient injury.The lesion was calcified but there was no vessel tortuosity.A peripheral interventional procedure had been performed.The access site was the femoral.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and no resistance/friction while inserting the balloon through the guide catheter.The balloon catheter did not kink while being used.Additional patient and procedural details were requested but were unknown.One product was returned for analysis.A non-sterile unit of a.014 5.0 x 40 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis coiled inside a plastic bag.No original packaging was returned for evaluation.Per visual analysis of the received aviator, severe kinks were observed on the body shaft of the unit at approximately 31.0 cm from the distal tip.No other anomalies were observed.Functional testing was performed on the unit despite the severely kinked condition of the body shaft.A lab sample inflator/deflator device partially filled with water was attached to the hub inflation lumen and pressure was applied.The balloon was successfully inflated.No anomalies observed.A product history record (phr) review of lot 82185849 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst - at/below rbp¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined.Per functional analysis, the balloon was inflated successfully with an indeflator; neither a leakage nor a burst was observed on the balloon.Based on the device analysis, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as balloon was not ruptured.However, there was a severe kink noted on the body shaft of the returned aviator balloon.As noted in the event description, the device did not kink while being used.Therefore, based on the information available for review, it is likely procedural factors and handling of the device for packing/shipping likely contributed to the kink noted upon analysis.According to the instructions for use ¿prior to use, the device should be examined to verify functionality and integrity, and ensure that its size is suitable for the specific procedure.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in-vitro testing.(b)(4).Use of a pressure-monitoring device is recommended to prevent over-pressurization.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: AVIATOR PLUS .014 5.0X40 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer (Section G): CARDINAL HEALTH MEXICO 244 S DE RL DE CV; santiago troncoso 808; juarez 32574 ; MX 32574
• Manufacturer Contact: karla castro ; 14201 nw 60th ave,; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13017960
• Report Number: 9616099-2021-05200
• Device Sequence Number: 20077735
• Product Code: LIT
• UDI-Device Identifier: 20705032005842
• UDI-Public: (01)20705032005842(17)221231(10)82185849,
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 12/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 4245040W
• Device Lot Number: 82185849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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
• Patient Sex: Unknown