MAUDE Adverse Event Report: CORDIS US. CORP POWERFLEX PRO; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4401206X
Medical Device Problem Codes	Material Frayed (1262); Structural Problem (2506); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 12mm 6cm powerflex balloon was pumped to the rated burst pressure but could not fill properly, and continued to increase the pressure and still could not fill.The balloon was changed to a non-cordis balloon, with the same pressure pump.The balloon could fill normally.It was suspected that the balloon was damaged, or the filling chamber was blocked.There was no reported injury to the patient.This occurred during an iliac vein compression surgery.Additional information was requested; however, the information was not obtained after multiple attempts.The device was returned for analysis.A non-sterile ¿powerflexpro 12mm6cm 135¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing the balloon presents an axial rupture.The second distal marker band is of out of position moved towards the center of the balloon.No other outstanding details were noticed.Functional testing was performed, an inflator/deflator device was attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.However, balloon inflation was not possible due to an axial tear on the balloon material.Sem results showed that the powerflexpro 12mm6cm 135 unit¿s balloon surface presented evidence of scratch marks located on the surface sections near the burst rupture borders.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface could have led to the damaged condition found on the received device.It seems the surface near the burst border area was affected with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82230283 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon inflation difficulty - unable to inflate¿ and subsequent findings of ¿balloon frayed/split/torn¿ and ¿marker band-balloon catheters - offset/out of position¿ were confirmed during device analysis and an axial rupture was identified on the returned device.Additionally, a distal markerband was noted towards the center of the balloon inner lumen.However, the exact cause of the events cannot be determined.Functional analysis was not possible due to the axial rupture noted on the balloon material.There is no mention of the displaced markerband in the original event description as reported making it difficult to determine the actual cause.Based on the information available for review it is difficult to draw a clinical conclusion between the device and the events reported.According to the safety information in the instructions for use, ¿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.If resistance is met during manipulation, determine the cause of the resistance before proceeding.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.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 events for both devices.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, the 12mm 6cm powerflex balloon was pumped to the rated burst pressure but could not fill properly, and continued to increase the pressure and still could not fill.The balloon was changed to a non-cordis balloon, with the same pressure pump.The balloon could fill normally.It was suspected that the balloon was damaged, or the filling chamber was blocked.There was no reported injury to the patient.This occurred during an iliac vein compression surgery.The device will be returned for evaluation.Additional information was requested; however, the information was not obtained after multiple attempts.The product evaluation showed the balloon was frayed/split and markerband-out of position.

• Brand Name: POWERFLEX PRO
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 CR201-02 ; CS CR20102 ; 7863138372
• MDR Report Key: 19175821
• Report Number: 3007635982-2024-00111
• Device Sequence Number: 3797724
• Product Code: LIT
• UDI-Device Identifier: 20705032072806
• UDI-Public: (01)20705032072806(17)240831(10)82230283
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

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
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 4401206X
• Device Lot Number: 82230283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMANDA .035; PP; SMART; TEMPO
• Patient Sex: Unknown