MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400704S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 7mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used for post-dilatation, but on the first inflation at eight atmospheric pressure (atm), it ruptured.They used the same size power flex balloon catheter for dilation; also, a saber 3mm and 4cm were used for pre-dilatation.A non-cordis stent graft placed, and the procedure was successfully completed.There was no reported patient injury.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing product from the hoop.No difficulty removing the protective balloon cover, inner stylet, or any other of the sterile packaging components.There were no kinks or other damages noted prior to inserting the device into the patient.The device was prepped normally.The procedure was endovascular treatment of the iliac artery.The patient had mild calcified lesions in the case of stenosis of iliac.The lesion had moderate calcification and had moderate tortuosity with 90% stenosis.The device was not used for treatment of a chronic total occlusion (cto).The device had no difficulty advancing through the vessel and crossed the lesion without difficulty.A non-cordis inflation device was used and was filled with 1:1 saline/contrast ratio.The indeflator was used successfully throughout the procedure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.No resistance/friction while inserting the balloon though the guide catheter.The catheter was never in an acute bend.The balloon catheter never kinked while being used.The device was removed from patient intact (in one piece).The device was not returned for analysis as it was discarded at the hospital.A product history record (phr) review of lot 82210776 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 exact cause could not be determined.Vessel characteristics of moderate calcification and tortuosity with 90% stenosis may have contributed to the reported event, as it is known that calcium may damage balloon material.However, without return of the product for analysis, it is difficult to draw a clinical conclusion between the device and the reported event.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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 7mm x 4cm x 80cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter was used for post-dilatation, but on the first inflation at 8 atmospheric pressure (atm), it ruptured.They used the same size power flex balloon catheter for dilation.Saber 3mm and 4cm were used for pre-dilatation.A non-cordis stent graft placed and the procedure was successfully completed.There was no reported patient injury.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing product from the hoop.No difficulty removing the protective balloon cover, inner stylet, or any other of the sterile packaging components.There were no kinks or other damages noted prior to inserting the device into the patient.The device was prepped normally.The procedure was endovascular treatment of the iliac artery.The patient had mild calcified lesions in the case of stenosis of iliac.The lesion had moderate calcification and had moderate tortuosity.The lesion had a 90% stenosis.The device was not used for treatment of a chronic total occlusion (cto).The device had no difficulty advancing through the vessel and crossed the lesion without difficulty.A non-cordis inflation device was used and was filled with 1:1 saline/contrast ratio.The indeflator was used successfully throughout the procedure.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.No resistance/friction while inserting the balloon though the guide catheter.The catheter was never in an acute bend.The balloon catheter never kinked while being used.The device was removed from patient intact (in one piece).A non-cordis stent was placed and the case was completed successfully.The device will not be returned for analysis as it was discarded at the hospital.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11894102
• Report Number: 9616099-2021-04584
• Device Sequence Number: 3400596
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: 20705032059692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/27/2021

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: 11/30/2023
• Device Model Number: 4400704S
• Device Catalogue Number: 4400704S
• Device Lot Number: 82210776
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1