MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 8X6 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4158060S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of an 8x6 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter leaked contrast at the proximal side of the balloon when inflated at five atmospheres (atm) pressure.The device was removed from the patient intact (in one piece).Another same size cordis balloon was used and worked well.The case was completed.There is no reported patient injury.The product was stored per labeling.The user is trained in the device.The device was used for a fistulagram.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally and was able to maintain negative pressure.A non-cordis inflation device was used to inflate the balloon.The device will not be returned for evaluation.
Event or Problem Description
As reported, the balloon of an 8x6 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter leaked contrast at the proximal side of the balloon when inflated at five atmospheres (atm) pressure.The device was removed from the patient intact (in one piece).Another same size cordis balloon was used and worked well.The case was completed.There is no reported patient injury.The product was stored per labeling.The user is trained in the device.The device was used for a fistulagram.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally and was able to maintain negative pressure.A non-cordis inflation device was used to inflate the balloon.The device will not be returned for evaluation.
Additional Manufacturer Narrative
As reported, the balloon of an 8x6 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter leaked contrast at the proximal side of the balloon when inflated at five atmospheres (atm) pressure.The device was removed from the patient intact (in one piece).Another same size cordis balloon was used and worked well.The case was completed with no reported patient injury.The product was stored per labeling and the user is trained in the device.The device was used for a fistulagram.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the device from the hoop, removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device was prepped normally and was able to maintain negative pressure.A non-cordis inflation device was used to inflate the balloon.The product was not returned for analysis.A product history record (phr) review of lot 82235501 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¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics and without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the safety information in the instructions for use ¿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 event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: POWERFLEX EXTREME 8X6 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15802414
• Report Number: 9616099-2022-06100
• Device Sequence Number: 14802984
• Product Code: LIT
• UDI-Device Identifier: 20705032001974
• UDI-Public: (01)20705032001974(17)240930(10)82235501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: 09/30/2024
• Device Model Number: 4158060S
• Device Catalogue Number: 4158060S
• Device Lot Number: 82235501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 12/09/2022
• Date Device Manufactured: 10/21/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC INFLATION DEVICE; UNKNOWN CORDIS BALLOON CATHETER
• Patient Age: 52 YR
• Patient Sex: Unknown