MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 4MM2CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4400402S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During use, it was reported that the 4x20mm 80cm powerflex pro balloon catheter (bc) was leaking when it was inflated in the patient and there was difficulty removing the balloon on the guidewire.There was no patient injury.Therefore, the powerflex pro and the unknown guidewire was removed together.The balloon was replaced with a new power flex pro (4x40), along with a new guidewire and the procedure was completed successfully.A power flex pro was inserted and was inflated at ten atmosphere (10 atm) during its initial inflation.However it was confirmed that a little of contrast medium leaked from the balloon edge.It was inflated at 10 atm during its second inflation but the same issue occurred again and it could not be inflated.The physician tried to remove the power flex pro but it could not be removed as the wire got stuck with the guidewire lumen.So it was removed together.The physician tried to remove the guidewire outside the patient but could not.The distal portion of the superficial femoral artery (sfa) which was not tortuous, or calcified with eighty percent stenosis, and to what degree.There were no difficulty inflating the balloon.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The inflation device was successfully used with other devices.The catheter has never been in an acute bend.The device was prepped per the instruction for use (ifu) with no anomalies noted during prep.Constant and dedicated saline source was not utilized through the balloon during insertion during prep.No other products went through the same balloon.No other information was provided.The device was not returned for analysis.A device history record (dhr) review of lot 82148890 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon leakage during positive pressure¿ and ¿guidewire lumen resistance/friction in patient¿ could not be confirmed as the device was not returned for analysis.The root cause of this leakage and resistance/friction reported could not be determined.Based on the information available for review, vessel characteristics and handling factors may have contributed to the leakage and resistance/friction during guidewire withdrawal reported.According to the instructions for use (ifu), 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.When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.If resistance is met during manipulation, determine the cause of the resistance before proceeding.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.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
During use, it was reported that the power flex pro balloon catheter was leaking when it was inflated in the patient and there was difficulty removing the balloon on the guidewire.There was no patient injury.Therefore, the power flex pro and the unknown guidewire was removed together.The balloon was replaced with a new power flex pro (4*40), along with a new guidewire and the procedure was completed successfully.A power flex pro was inserted and was inflated at ten atmosphere (10 atm) during its initial inflation.However it was confirmed that a little of contrast medium leaked from the balloon edge.It was inflated at 10 atm during its second inflation but the same issue occurred again and it could not be inflated.The physician tried to remove the power flex pro but it could not be removed as the wire got stuck with the guidewire lumen.So it was removed together.The physician tried to remove the guidewire outside the patient but could not.The distal portion of the superficial femoral artery which was not tortuous, or calcified with eighty percent stenosis.And to what degree.There were no difficulty inflating the balloon.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The inflation device was successfully used with other devices.The catheter has never been in an acute bend.The device was prepped per the instruction for use (ifu) with no anomalies noted during prep.Constant and dedicated saline source was not utilized through the balloon during insertion during prep.No other products went through the same balloon.The device is not available for analysis.No other information was provided.

• Brand Name: POWERFLEXPRO 4MM2CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8079536
• Report Number: 9616099-2018-02534
• Device Sequence Number: 16525725
• Product Code: LIT
• UDI-Device Identifier: 20705032059128
• UDI-Public: 20705032059128
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 11/30/2020
• Device Model Number: 4400402S
• Device Catalogue Number: 4400402S
• Device Lot Number: 82148890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1