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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: an aviator plus (.014 7.0mm x 20cm x 142cm) percutaneous transluminal angioplasty (pta) balloon catheter (bc) balloon ruptured due to the calcified vessel.The product was not returned for analysis.A product history record (phr) review of lot 17718759 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.Vessel characteristics of calcification may have contributed to the reported event, as the presence of calcification is known to cause damage to balloons.According to the instructions for use, which are not intended to mitigate risk, ¿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/preventive action will be taken at this time.
Event or Problem Description
As reported, an aviator plus (.014 7.0x20 142cm) percutaneous transluminal angioplasty (pta) balloon catheter (bc) balloon ruptured due to the calcified vessel.There was no reported patient injury.
Additional Manufacturer Narrative
Updated complaint conclusion: an aviator plus (.014 7.0mm x 20mm x 142cm) percutaneous transluminal angioplasty (pta) balloon catheter (bc) balloon ruptured due to the calcified vessel.One product was returned for analysis.A non-sterile aviator plus.014 7.0mm x 20mm x 142cm balloon catheter was returned.Per visual analysis, the catheter was coiled inside a plastic bag and was previously inflated/deflated.No anomalies were observed.Sem analysis was performed to identify the possible root cause of the rupture.Results showed that the balloon leakage was caused by a rupture on the balloon surface.The external surface of the balloon presented evidence of bulged/peeled balloon material as well as scratch marks adjacent to the balloon rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.It is very likely the same factors that caused the bulged/peeled balloon material and scratch marks on the balloon outer surface led to the rupture on the balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 17718759 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ was confirmed through device analysis.However, the exact cause could not be determined.Device analysis revealed the balloon outer surface had bulged/peeled balloon material and scratch marks.This type of damage is commonly caused when balloon material encounters a sharp object or mechanical damage.It is likely vessel characteristics such as calcification may have contributed to the reported event, as the presence of calcification is known to cause damage to balloons.According to the instructions for use, which are not intended to mitigate risk, ¿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/preventive action will be taken at this time.

• 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: 8451710
• Report Number: 9616099-2019-02805
• Device Sequence Number: 2988970
• Product Code: LIT
• UDI-Device Identifier: 20705032005941
• UDI-Public: 20705032005941
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 05/24/2019

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: 08/31/2020
• Device Model Number: 4247020W
• Device Catalogue Number: 4247020W
• Device Lot Number: 17718759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1