MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 9MM2CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400902X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
During use for a post dilation of a competitor's stent, the power flex pro ruptured within its nominal pressure.There was no patient injury.The lesion was the iliac artery which was mildly tortuosity, moderate calcification and seventy percent stenosis.The balloon was prep according to the instruction for use (ifu).There were no difficulties 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 the product into the patient.A competitor's contrast media and inflation device was used.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The product removed intact (in one piece) from the patient.The device was discarded and is not available for analysis.No other information was provided.
Additional Manufacturer Narrative
A power flex pro ruptured within its nominal pressure during use for a post dilation of a non-cordis stent.There was no reported patient injury.The lesion was the iliac artery which had mildly tortuosity, moderate calcification and seventy percent stenosis.The balloon was prepped according to the instruction for use (ifu).There were no difficulties 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.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The inflation device was successfully used with other devices.The product removed intact (in one piece) from the patient.The device was not returned for analysis.A product history record (phr) review of lot 17722784 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, such as tortuosity, calcification and stenosis, may have contributed to the reported event.However, 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, ¿balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least (b)(4) of the balloons (with a (b)(4) 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 9MM2CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9243433
• Report Number: 9616099-2019-03309
• Device Sequence Number: 306064
• Product Code: LIT
• UDI-Device Identifier: 20705032059906
• UDI-Public: 20705032059906
• 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): 11/13/2019

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: 09/30/2020
• Device Model Number: 4400902X
• Device Catalogue Number: 4400902X
• Device Lot Number: 17722784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/27/2019
• Supplement Report FDA Received Date: 11/13/2019
• 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: STENT (LUMINEXX, C. R. BARD)