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

Catalog Number	4401206X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 82287438 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 12mm 6cm powerflex pro percutaneous transluminal angioplasty (pta) balloon leaked during use.It was also noted that there was difficulty advancing the balloon catheter through the vessel.The case was completed with a new cordis 12x60 balloon.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification.The vessel was noted to have moderate tortuosity.The lesion had a 50% stenosis.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/ friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/ friction while inserting the balloon through the unknown guide catheter.The catheter was never in an acute bend and was never kinked during use.The saline/contrast ratio was noted to be 1:1.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: d9, g3, g6, h1, h2, h3 and h6.As reported, a 12mm x 6cm powerflex pro percutaneous transluminal angioplasty (pta) balloon leaked during use.It was also noted that there was difficulty advancing the balloon catheter through the vessel.The case was completed with a new cordis 12x60 balloon.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop, removing the protective balloon, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the device into the patient.The device was prepped per the ifu and was able to maintain negative pressure.The lesion was noted to have moderate calcification and 50% stenosis.The vessel was noted to have moderate tortuosity.The device was not being used to treat a chronic total occlusion (cto).There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or while inserting through the unknown guide catheter.The catheter was never in an acute bend and was never kinked during use.The saline/contrast ratio was noted to be 1:1.The product 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 placed on a metallic tray to be inspected.A thorough inspection was performed on the unit observing no damages or anomalies.No other outstanding details were noticed.Functional testing was performed using an inflator/deflator device attached to the inflation port, positive pressure was applied with the purpose of reaching the rated burst pressure.However, inflation was not possible due to a leakage condition on the ballon from two pin holes.Sem analysis was not performed as the damages associated with leakage were visible with the magnification obtained with a vision system.The balloon was inspected observing two pin holes on the surface where the water is leaking.The balloon surface presented evidence of a punctured condition and secondary scratch marks located near the damaged area.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 probably led to the damaged condition found on the received device.It seems that the material near the damaged area was affected with a sharp object from the outside of the device.The reported ¿balloon leakage¿ was confirmed as a leakage from the balloon was noted during functional analysis of the returned device.However, the exact cause cannot be determined.The outer surface balloon material presented evidence of two punctures and scratch marks adjacent to the damages.The balloon material appears to have been punctured with a sharp object from the outside of the balloon.Based on the information available for review, it is likely procedural factors and vessel characteristics of calcification and stenosis contributed to the event reported as evidenced by device analysis.The reported ¿pta system - tracking difficulty¿ cannot be confirmed due to the nature of the event as this cannot be replicated in the lab setting.Difficulty crossing a lesion, or an anatomical structure and/or stent is a known procedural occurrence.Crossing difficulty is most commonly related to patient anatomy, operator technique and appropriate device selection.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the events reported by the customer as no anomalies were noted on the device.According to the safety information in the instructions for use, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.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.¿ the information available does not suggest 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.

• 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 ; 7863138372
• MDR Report Key: 19552863
• Report Number: 3007635982-2024-00160
• Device Sequence Number: 4811365
• Product Code: LIT
• UDI-Device Identifier: 20705032072806
• UDI-Public: (01)20705032072806(17)260731(10)82287438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 07/31/2026
• Device Catalogue Number: 4401206X
• Device Lot Number: 82287438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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: CORDIS 5F SHEATH, 5F MPACATH.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 60 KG