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

Catalog Number	4400408X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the balloon of a 4mm8cm 135 powerflex pro percutaneous transluminal angioplasty (pta) dilation catheter was found to have a hole when being inflated.The balloon was caught in the lesion, and able to be removed intact easily from the patient.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The hole was found just as the device was inflated.The device maintained negative pressure during preparation for 4 seconds.The device was inflated to 8 atmospheres before the anomaly was noted.There were no visible signs of device or package damage prior to use.There was no difficulty removing the protective balloon cover, or any of the sterile packaging components.The gauge of the indeflator indicated a loss of pressure when the anomaly was noted.A contralateral approach was used.The target vessel was the superficial femoral artery.The target vessel site had mild calcification and tortuosity.There was 35% stenosis and there was no acute angle or bifurcation.The device was no put into an acute bend at any point during the procedure.The device was able to cross the lesion.The device did not kink at any time during the procedure.There were no anomalies noted after the device was delivered to the lesion.The balloon was caught in the lesion.The balloon was not caught in a deployed stent.The device is being returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, the balloon of a 4mm8cm 135 powerflex pro percutaneous transluminal angioplasty (pta) dilation catheter was found to have a hole when being inflated.The balloon was caught in the lesion, and able to be removed intact easily from the patient.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The hole was found just as the device was inflated.The device maintained negative pressure during preparation for 4 seconds.The device was inflated to 8 atmospheres before the anomaly was noted.There were no visible signs of device or package damage prior to use.There was no difficulty removing the protective balloon cover, or any of the sterile packaging components.The gauge of the indeflator indicated a loss of pressure when the anomaly was noted.A contralateral approach was used.The target vessel was the superficial femoral artery.The target vessel site had mild calcification and tortuosity.There was 35% stenosis and there was no acute angle or bifurcation.The device was no put into an acute bend at any point during the procedure.The device was able to cross the lesion.The device did not kink at any time during the procedure.There were no anomalies noted after the device was delivered to the lesion.The balloon was caught in the lesion.The balloon was not caught in a deployed stent.The product was returned for analysis.A non-sterile ¿powerflex pro 4mm8cm 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.The unit was thoroughly inspected observing that no damages or anomalies were observed during the unaided eye visual inspection.The balloon was received deflated.No other outstanding details were noted.Functional testing was performed using an inflator/deflator device attached to the inflation port.Balloon inflation was done by applying positive pressure using the inflator/deflator device with the purpose of reaching the rated burst pressure.The balloon was inflated as expected and the pressure remained steady.No anomalies were observed during the inflation test.A product history record (phr) review of lot 82218331 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¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined as the device passed functional analysis.The balloon was inflated/deflated with no burst or leaks noted and without any anomalies noted to the balloon.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.¿ 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.

• 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: 19056912
• Report Number: 3007635982-2024-00089
• Device Sequence Number: 7949537
• Product Code: LIT
• UDI-Device Identifier: 20705032059197
• UDI-Public: (01)20705032059197(17)240229(10)82218331
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 4400408X
• Device Lot Number: 82218331
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 05/23/2024
• Initial Report FDA Received Date: 04/07/2024
• Supplement Report FDA Received Date: 05/06/2024; 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2021
• 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: UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 78 KG