MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 10MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the balloon of 10mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter had ruptured during use.There was no reported patient injury.The lesion was at the iliac artery with calcification.The lesion was severely calcified.The vessel tortuosity was severe.The percentage of stenosis was 80%.The device was not used for a chronic total occlusion (total occlusion >3 months).The product was removed intact (in one piece) from the patient.There was no difficulty advancing the balloon catheter through the vessel.There was difficulty crossing the lesion.The catheter was in an acute bend.There was no difficulty removing the product from the hoop and when removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The user was unable to depress the plunger into the syringe/indeflator when trying to inflate.The balloon inflated normally.The balloon did not maintain pressure during inflation.The balloon burst.The shaft did not burst.The balloon did not seem to ¿stick¿ to a stent.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The device was not returned for analysis as it was discarded by mistake.A product history record (phr) review of lot 82181639 revealed no anomalies or non-conformance's 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 severe calcification and tortuosity with 80% 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 balloon of 10mm x 4cm 135cm powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter had ruptured during used.There was no reported patient injury.The lesion was at the iliac artery with calcification.The lesion was severely calcified.The vessel tortuosity was severe.The percentage of stenosis was 80%.The device was not used for a chronic total occlusion (total occlusion >3 months).The product was removed intact (in one piece) from the patient.There was no difficulty advancing the balloon catheter through the vessel.There was difficulty crossing the lesion.The catheter was in an acute bend.There was no difficulty removing the product from the hoop and when removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or through the guide catheter.The user was unable to depress the plunger into the syringe/indeflator when trying to inflate.The balloon inflated normally.The balloon did not maintain pressure during inflation.The balloon burst.The shaft did not burst.The balloon did not seem to ¿stick¿ to a stent.The balloon catheter did not kink while being used.The balloon catheter was removed easily.The device will not be returned for evaluation as it was discarded by mistake.

• Brand Name: POWERFLEXPRO 10MM4CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10351982
• Report Number: 9616099-2020-03819
• Device Sequence Number: 19454276
• Product Code: LIT
• UDI-Device Identifier: 20705032060063
• UDI-Public: 20705032060063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• 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): 07/31/2020

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: 10/31/2022
• Device Model Number: 4401004X
• Device Catalogue Number: 4401004X
• Device Lot Number: 82181639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1