MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 5MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400504S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with lot 82166089 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, a non-cordis guidewire crossed the lesion and a powerflex pro 5mm4cm 80 was inserted, however, it could not cross the lesion, the doctor attempted several times by pushing it, but it still did not cross.The powerflex pro was connected with an inflation device for pre inflation, when it was deflated, back-flow was confirmed.The powerflex pro balloon ruptured before the inflation.There were no reported patient injuries.The balloon was replaced with a same size saber balloon catheter.It could cross the lesion and be inflated.A smart stent was then implanted, and the procedure was completed.The lesion was the common iliac artery and the external iliac artery.An ipsilateral retrograde was made.The vessel was heavily calcified and moderately tortuous.
Additional Manufacturer Narrative
Section b5: addendum for additional information received:there was ninety percent stenosis and the device was not used for a chronic total occlusion (cto).The device was brought to the cath lab the day of the procedure.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon catheter was easily removed and was removed intact.A non-cordis guidewire crossed the lesion and a powerflex pro 5mm x 4cm 80cm balloon catheter (bc) was inserted; however, it could not cross the lesion, therefore the doctor attempted several times by pushing it, but it still did not cross.The lesion was the common iliac artery and the external iliac artery.An ipsilateral retrograde was made.The vessel was heavily calcified and moderately tortuous.There was ninety percent stenosis and the device was not used for a chronic total occlusion (cto).The powerflex pro was connected with an inflation device for pre inflation, when it was deflated, back-flow was confirmed.The powerflex pro balloon ruptured before the inflation.There were no reported patient injuries.The balloon was replaced with a same size saber balloon catheter.It could cross the lesion and be inflated.A smart stent was then implanted, and the procedure was completed.The device was brought to the cath lab the day of the procedure.The device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.The same indeflator was used successfully with other devices.There were no kinks or other damages noted prior to inserting the product into the patient.The balloon catheter was easily removed and was removed intact.The product was not returned for analysis.A product history record (phr) review of lot 82166089 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 heavy calcification and moderate tortuosity and a rate of stenosis of 90% may have contributed to 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/preventive action will be taken at this time.

• Brand Name: POWERFLEXPRO 5MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8744813
• Report Number: 9616099-2019-03044
• Device Sequence Number: 13825264
• Product Code: LIT
• UDI-Device Identifier: 20705032059326
• UDI-Public: 20705032059326
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: 01/31/2022
• Device Catalogue Number: 4400504S
• Device Lot Number: 82166089
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/12/2019
• 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: GUIDEWIRE RADIFOCUS, TERUMO); SABER, CORDIS; SMART STENT