MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 12MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401204S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During use, it was reported that the power flex pro ruptured at six atmosphere (6 atm) which was within its rated balloon pressure.There was no patient injury.The lesion was the iliac artery with calcification.
Additional Manufacturer Narrative
Additional information was received and section was updated below.During use, it was reported that the power flex pro ruptured at six atmosphere (6 atm) which was within its rated balloon pressure.There was no patient injury.The lesion was the iliac artery with calcification.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.The device is not available for analysis.No other information was provided.
Additional Manufacturer Narrative
During use, it was reported that the 12x40cm 80cm powerflex pro balloon catheter (bc) ruptured at six atmosphere (6 atm) which was within its rated balloon pressure.There was no patient injury.The lesion was the iliac artery with calcification.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.The device is not available for analysis.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 17703241 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 of the burst could not be determined.Based on the limited information available for review, vessel characteristics (calcification) and procedural/handling factors may have contributed to the reported event since calcified/resistant lesions can cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the result of in vitro testing.At least 99.9% of the balloons (with a 95% confidence level) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.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 dhr review 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.
Additional Manufacturer Narrative
During use, it was reported that the power flex pro ruptured at six atmosphere (6 atm) which was within its rated balloon pressure.There was no patient injury.The lesion was the iliac artery with calcification.There is no information about handling, prep or condition of the device when it was removed from the packaging.The device was not returned for analysis.A device history record (dhr) review of lot 17703241 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 (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, vessel characteristics of calcification may have contributed to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation, per 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 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 dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: POWERFLEXPRO 12MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7735032
• Report Number: 9616099-2018-02272
• Device Sequence Number: 2580359
• Product Code: LIT
• UDI-Device Identifier: 20705032060179
• UDI-Public: 20705032060179
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2018

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: 06/30/2020
• Device Model Number: 4401204S
• Device Catalogue Number: 4401204S
• Device Lot Number: 17703241
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 08/20/2018; 09/24/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/27/2018; 09/19/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1