MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 7.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4247020W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: the aviator plus 0.14 7.0mm x 20mm 142cm percutaneous transluminal angioplasty (pta) catheter was used but ruptured.The maximum inflation pressure was 8 atmospheres (atm).There was no reported patient injury.The procedure was a balloon pulmonary angioplasty (bpa).The lesion had a little calcification.The vessel tortuosity was little with 99% stenosis.The device was not used for a chronic total occlusion.The device was stored and handled per the instructions for use (ifu).There was no difficulty in removing the product from the hoop and protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prepped as per the instruction for use (ifu).The device was prepped normally (i.E.Maintaining negative pressure).The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and through the guide catheter.The catheter was in an acute bend.The device had to pass through a previously placed stent.The balloon burst during its initial inflation.No unusual force was used at any time during the procedure.The product was removed intact (in one piece) from the patient.The product was not returned for analysis due to the patient¿s suspected infectious disease.A product history record (phr) review of lot 17742400 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the information available for review, vessel characteristics (vessel was tortuous with 99% rate of stenosis) may have contributed to the reported event since a calcified/resistant lesion can cause damage to the balloon.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.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.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.
Event or Problem Description
As reported, the.014 7.0x20 142cm aviator plus was used but ruptured.The procedure was balloon pulmonary angioplasty (bpa).The lesion had a little calcification.The device was replaced by a smaller aviator plus balloon catheter and the94 procedure was completed.There was no reported patient injury.The vessel tortuosity was little with 99% stenosis.The device was not used for a chronic total occlusion.The device was stored and handled per the instructions for use (ifu).There was no difficulty in removing the product from the hoop and protective balloon cover, or the stylet or any of the sterile packaging components.There were no kinks nor other damages noted prior to inserting the product into the patient.The device was prep as per the instruction for use (ifu).The device was prepped normally (i.E.Maintaining negative pressure).The same indeflator was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and through the guide catheter.The catheter was in an acute bend.The device had to pass through a previously placed stent.The maximum inflation pressure was 8 atmospheres (atm).The balloon burst during its initial inflation.No unusual force was used at any time during the procedure.The product was removed intact (in one piece) from the patient.The device will not be returned for evaluation due to suspected infectious disease.

• Brand Name: AVIATOR PLUS .014 7.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9281386
• Report Number: 9616099-2019-03334
• Device Sequence Number: 2183575
• Product Code: LIT
• UDI-Device Identifier: 20705032005941
• UDI-Public: 20705032005941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: 11/30/2020
• Device Model Number: 4247020W
• Device Catalogue Number: 4247020W
• Device Lot Number: 17742400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1