MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 4.0X15 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4244015W
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17612844 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the.014 4.0 x 15 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) ruptured at twelve atmospheres (12atm) during its initial inflation.The procedure was therefore completed using another balloon catheter and a cutting catheter.There was no reported patient injury.The lesion was at the right popliteal artery which noted to have severe calcification and extremely short severe stenosis.A contralateral approach was made using a non-cordis guiding catheter.A non-cordis guidewire had crossed the lesion.The device will not be returned as it was discarded by mistake.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, and h6 have been updated accordingly.A.014mm 4.0mm x 15mm 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used but it ruptured at twelve atmospheres during its initial inflation.There was no reported patient injury.The lesion was at the right popliteal artery which noted to have severe calcification and extremely short severe stenosis.A contralateral approach was made using a non-cordis guiding catheter.A non-cordis guidewire had crossed the lesion.The procedure was completed using another balloon catheter and a cutting catheter.The device was not returned for analysis as it was discarded.A product history record (phr) review of lot 17612844 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¿ could not be confirmed as the device was not returned for analysis.The cause of balloon burst could not be conclusively determined.Vessel characteristics, such as severe calcification and severe stenosis, may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation of 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 4.0X15 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9349777
• Report Number: 9616099-2019-03362
• Device Sequence Number: 18906571
• Product Code: LIT
• UDI-Device Identifier: 20705032005736
• UDI-Public: 20705032005736
• 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: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 09/30/2019
• Device Catalogue Number: 4244015W
• Device Lot Number: 17612844
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4MM*1.5MM UNK CUTTING BALLOON CATHETER; 6F TERUMO GUIDING CATHETER; VASSALLO/NS3/235, FILMEC GUIDEWIRE