MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 8MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400802S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An 8mm x 2cm powerflex pro 80 percutaneous transluminal angioplasty (pta) balloon catheter was attempted to be used for post dilation of an iliac artery lesion; however, the balloon ruptured within its nominal pressure.There was no patient injury reported.The procedure was completed using another non-cordis balloon catheter.The device was stored and prepped normally per the instructions for use (ifu).There was no visible damage to the packaging.There was no difficulty removing the product from the hoop, the protective balloon cover, 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.An unknown indeflator was used successfully with other devices.There was no difficulty advancing the balloon catheter through the vessel or crossing the lesion.The catheter was never in an acute bend.The plunger did depress into the syringe/indeflator when trying to inflate and the balloon did inflate normally.The product was removed intact from the patient.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 17648036 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, although unknown, may have contributed to the reported event.However, with the limited amount of information provided regarding lesion characteristics and without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the event reported.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, an 8mmx2cm powerflex pro 80 percutaneous transluminal angioplasty (pta) balloon catheter was attempted to be used post dilation for an iliac artery lesion, however, balloon ruptured within its nominal pressure.The procedure was completed using another non cordis balloon catheter.There was no patient injury reported.The device was stored and prepped as per the instructions for use (ifu).There was no visible damage to packaging.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 device prepped normally.An unknown indeflator was used successfully with the other devices.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The catheter was never in an acute bend.The plunger did depress into the syringe/indeflator when trying to inflate and the balloon did inflate normally.The product was removed intact from the patient.The device will not be returned for evaluation because it was discarded.

• Brand Name: POWERFLEXPRO 8MM2CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9792349
• Report Number: 9616099-2020-03551
• Device Sequence Number: 16690563
• Product Code: LIT
• UDI-Device Identifier: 20705032059777
• UDI-Public: 20705032059777
• 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): 03/05/2020

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: 01/31/2020
• Device Model Number: 4400802S
• Device Catalogue Number: 4400802S
• Device Lot Number: 17648036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1