MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 12MM6CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4401206X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2017
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, the powerflex pro 12mm 6cm 135 ruptured in a calcified common illiac vessel.There were no patient injury.The balloon inflate normally.There was no difficulty inflating the balloon during prep.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.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or advancing the balloon catheter through the vessel.The catheter ever in an acute bend.There was no difficulty crossing the lesion.The type and brand of inflation device was indeflator which was successfully used with other devices.The product was removed intact (in one piece) from the patient.The device will not be returned for analysis as the device was discarded.
Additional Manufacturer Narrative
During use, the 12x60mm 135cm powerflex pro percutaneous transluminal angioplasty (pta) catheter ruptured in a calcified common illiac vessel.There were no patient injury.The balloon inflate normally.There was no difficulty inflating the balloon during prep.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.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or advancing the balloon catheter through the vessel.The catheter ever in an acute bend.There was no difficulty crossing the lesion.The type and brand of inflation device was indeflator which was successfully used with other devices.The product was removed intact (in one piece) from the patient.The device was not returned for analysis due to infectious disease.A device history record (dhr) review of lot 17635448 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 (calcified) may have contributed to the reported event as calcification/resistant lesions may 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 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.Do not exceed the rated burst pressure recommended on the label.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 at this time.

• Brand Name: POWERFLEXPRO 12MM6CM 135
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7145228
• Report Number: 9616099-2017-01725
• Device Sequence Number: 11049004
• Product Code: LIT
• UDI-Device Identifier: 20705032072806
• UDI-Public: 20705032072806
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 12/31/2019
• Device Model Number: 4401206X
• Device Catalogue Number: 4401206X
• Device Lot Number: 17635448
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/25/2017
• Initial Date Received by Manufacturer: 11/25/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/23/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1