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

Catalog Number	4400504X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
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.E1: phone (b)(6).
Event or Problem Description
As reported, the balloon of the 5mm 4cm power flex pro percutaneous transluminal angioplasty (pta) device ruptured during the procedure.The procedure was completed using another powerflex pro balloon catheter.There was no reported injury to the patient.The device was stored and prepared in accordance with the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.No kinks or damages were noted prior to inserting the product into the patient.The lesion was minimally calcified, and the vessel tortuosity was also minimal.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.Additionally, there were no issues advancing the balloon catheter through the vessel or crossing the lesion.The balloon catheter did not kink during use, and it was removed intact from the patient.It will be returned for further analysis and evaluation.
Additional Manufacturer Narrative
As reported, the balloon of the 5mm 4cmpowerflex pro percutaneous transluminal angioplasty (pta) device ruptured during the procedure.The procedure was completed using another powerflex pro balloon catheter.There was no reported injury to the patient.The device was stored and prepared in accordance with the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.No kinks or damages were noted prior to inserting the product into the patient.The lesion was minimally calcified, and the vessel tortuosity was also minimal.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.Additionally, there were no issues advancing the balloon catheter through the vessel or crossing the lesion.The balloon catheter did not kink during use, and it was removed intact from the patient.A non-sterile unit of ¿powerflexpro 5mm4cm 135¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.A thorough inspection was performed observing that the unit does not present any damages or anomalies.The balloon arrived not inflated.No other outstanding details were observed.Functional test was performed.One inflator/deflator device was attached to the inflation port.Balloon inflation test was done applying positive pressure using the inflator/deflator device with the purpose of reach the rate burst pressure.However, inflation pressure is not maintained due to a leak in the balloon caused by a rupture on the surface.The balloon was inspected with a vision system observing a rupture on the surface where the water is leaking.The balloon surface presented evidence of a ruptured condition and secondary scratch marks located near the damaged border area.The failure reported by the customer as ¿balloon~burst¿ was confirmed.A ruptured condition was observed on the balloon surface that generated a leak, impeding the ability to maintain the inflation pressure.The exact cause of this condition observed on the balloon could not be conclusive determined during the analysis.Procedural factors and handling process may have contributed to the failure as reported.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 probably led to the damaged condition found on the received device.It seems the material near the damages was ruptured with a sharp object from the outside of the device resulting in the torn of the balloon.As per the ifu, use only the recommended balloon inflation medium of 50/50 contrast/saline.The catheter should only be used by trained physicians.Balloon inflation should be performed with the guidewire extended beyond the catheter tip.Inflation at high rate may damage the balloon.If at any point during insertion of the catheter resistance is felt, withdraw the entire system.The product analysis does not suggest that the observed damage could be related to the manufacturing process; therefore, no corrective action will be taken at this time.
Event or Problem Description
As reported, the balloon of the 5mm 4cmpowerflex pro percutaneous transluminal angioplasty (pta) device ruptured during the procedure.The procedure was completed using another powerflex pro balloon catheter.There was no reported injury to the patient.The device was stored and prepared in accordance with the instructions for use (ifu).There was no difficulty removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.No kinks or damages were noted prior to inserting the product into the patient.The lesion was minimally calcified, and the vessel tortuosity was also minimal.There was no resistance or friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.Additionally, there were no issues advancing the balloon catheter through the vessel or crossing the lesion.The balloon catheter did not kink during use, and it was removed intact from the patient.It will be returned for further analysis and evaluation.

• 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: 20819067
• Report Number: 3007635982-2024-00277
• Device Sequence Number: 18374893
• Product Code: LIT
• UDI-Device Identifier: 20705032059333
• UDI-Public: (01)20705032059333(17)250430(10)82248563
• 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
• Report Date (Section B): 01/17/2025

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: 04/30/2025
• Device Catalogue Number: 4400504X
• Device Lot Number: 82248563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• 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: 01/13/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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 Sex: Unknown