MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM2CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400802X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 135 8mm x 2cm powerflex pro percutaneous transluminal angioplasty (pta) catheter was inserted, however, it ruptured at 10 atmospheres (atm).The doctor felt a little resistance advancing the balloon catheter through the vessel.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.There was no patient injury reported.The device was replaced with a new powerflex pro balloon catheter and was successfully inflated.The lesion was the right external iliac artery with stenosis.The lesion had moderate calcification.There was little vessel tortuosity.The percentage stenosis was 90%.The device was not used for a chronic total occlusion.The product was stored and handled according to the instructions for use (ifu) the product was inspected and prepped according to the ifu.The device did prep normally.There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop.There was no difficulty 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 balloon catheter did not kink while being used.The same indeflator was used successfully with other devices.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The maximum inflation pressure was 10 atmosphere (atm).There was no unusual force used at any time during the procedure.The device will not be returned for analysis due to suspicious infectious disease.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h1, h2, and h6 have been updated accordingly.A 135 8mm x 2cm powerflex pro percutaneous transluminal angioplasty (pta) catheter was inserted; however, it ruptured at 10 atmospheres (atm).The lesion was the right external iliac artery with stenosis.The lesion had moderate calcification.There was little vessel tortuosity.The percentage stenosis was 90%.The doctor felt a little resistance advancing the balloon catheter through the vessel.The balloon catheter was removed easily.The product was removed intact (in one piece) from the patient.There was no patient injury reported.The device was replaced with a new powerflex pro balloon catheter and was successfully inflated.The device was not used for a chronic total occlusion.The product was stored and handled according to the instructions for use (ifu) the product was inspected and prepped according to the ifu.The device did prep normally.There was nothing unusual noted about the device prior to use.There was no difficulty removing the product from the hoop.There was no difficulty 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 balloon catheter did not kink while being used.The same indeflator was used successfully with other devices.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The maximum inflation pressure was 10atm.There was no unusual force used at any time during the procedure.The product was not returned for analysis.A product history record (phr) review of lot 82148552 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¿ and ¿pta/ptca system tracking difficulty¿ 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 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 8MM2CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8735433
• Report Number: 9616099-2019-03038
• Device Sequence Number: 14096414
• Product Code: LIT
• UDI-Device Identifier: 20705032059784
• UDI-Public: 20705032059784
• 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,Followup
• Report Date (Section B): 07/03/2019

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: 10/31/2020
• Device Model Number: 4400802X
• Device Catalogue Number: 4400802X
• Device Lot Number: 82148552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: POWERFLEX PRO CATHETER.; POWERFLEX PRO CATHETER