MAUDE Adverse Event Report: CORDIS CASHEL AVIATOR PLUS .014 5.0X15 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4245015W
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 5.0 x 15 aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used for the renal artery with a stent graft backup; however, the shaft of the aviator plus cracked while it was pushed to secure the renal artery.No patient injury was reported.The device was replaced with a new different length aviator plus and the procedure was continued.The intended treatment site and target lesion was the renal artery.The lesion had a little calcification, moderate angulation, and moderate tortuosity.The percentage of stenosis was seventy-five percent.The device was stored, handled, inspected, and prepped normally according to the instructions for use (ifu).The device was not used for a chronic total occlusion (cto).There were no kinks or other damages noted prior to inserting the product into the patient.There was no difficulty advancing the device to the target lesion.Excessive torquing was not required.There was no resistance met while advancing the device over the guidewire.There were no stents present within the treatment site or the tracking path.There was no resistance met while withdrawing the device.The product was removed intact (in one piece) from the patient.The device was not returned for analysis.A product history record (phr) review of lot 17550380 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft cracked-in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.However, vessel characteristics of calcification, moderate angulation, and tortuosity may have contributed to the reported event.The lesion is also described as having seventy-five percent stenosis, it is likely that during the attempt to cross the stenosed lesion damage may have occurred to the shaft of the catheter.According to the warnings in 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.Caution: if strong resistance is met during advancement or withdrawal of the balloon catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.Note: if the balloon cannot be withdrawn through the guiding catheter, withdraw the balloon catheter and guiding catheter as a single unit.¿ 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, the 5.0x15 aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) was used for the renal artery with a stent graft backup, however the shaft of the aviator plus cracked while it was pushed to secure the renal artery.No patient injury was reported.The device was replaced with a new, different length aviator plus and the procedure was continued.The intended treatment site and target lesion was the renal artery.The lesion had a little calcification, moderate angulation, and moderate tortuosity.The percentage of stenosis was seventy-five percent.The device was stored, handled, inspected, and prepped according to the instructions for use (ifu), and it prepped normally.The device was not used for a chronic total occlusion (cto).There were no kinks or other damages noted prior to inserting the product into the patient.There was no difficulty advancing the device to the target lesion.Excessive torquing was not required.There was no resistance met while advancing the device over the guidewire.There were no stents present within the treatment site or the tracking path.There was no resistance met while withdrawing the device.The product was removed intact (in one piece) from the patient.The device will not be returned for evaluation as it was discarded in the hospital.

• Brand Name: AVIATOR PLUS .014 5.0X15 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 8816115
• Report Number: 9616099-2019-03091
• Device Sequence Number: 343177
• Product Code: LIT
• UDI-Device Identifier: 20705032005811
• UDI-Public: 20705032005811
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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: 07/31/2019
• Device Catalogue Number: 4245015W
• Device Lot Number: 17550380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/23/2019
• 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: AVIATOR PLUS
• Patient Age: 74 YR
• Patient Weight: 63