MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 8X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4158040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the balloon of an 8mm x 4cm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 10 atmospheres (atm).As a result, the 8mm x 4cm 80cm powerflex extreme pta balloon catheter was removed, and a 9mm x 4cm 80cm powerflex extreme pta balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during an interventional procedure to treat a 90% focal stenosis of the proximal cephalic vein.The target lesion was not a chronic total occlusion (cto) and there was no calcification or tortuosity present.The device was stored and prepped per the instructions for use (ifu).A 50/50 contrast and saline mixture was used to prep the balloon which maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced as the 8mm x 4cm 80cm powerflex extreme was inserted into the patient.The device was able to track toward the lesion and cross the lesion without issue.The device was never put into an acute bend during this procedure, and it did not kink during its use.After the balloon rupture, the device was removed without issue and remained intact during its removal from the patient.Information regarding the patient was requested but not provided.The device was not returned for analysis.A product history record (phr) review of lot 82230363 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics and procedural factors may have contributed to the reported event.A heavily stenosed lesion may damage balloon material when attempting to cross the lesion.However, with the information available and without return of the product for analysis it is difficult to draw a clinical conclusion between the device and the reported event.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.
Event or Problem Description
As reported, the balloon of an 8mm x 4cm 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured during an inflation to 10 atmospheres (atm).As a result, the 8mm x 4cm 80cm powerflex extreme pta balloon catheter was removed, and a 9mm x 4cm 80cm powerflex extreme pta balloon catheter was successfully used to complete the procedure.There was no reported injury to the patient.This was during an interventional procedure to treat a 90% focal stenosis of the proximal cephalic vein.The target lesion was not a chronic total occlusion (cto) and there was no calcification or tortuosity present.The device was stored and prepped per the instructions for use (ifu).A 50/50 contrast and saline mixture was used to prep the balloon which maintained negative pressure during preparation.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced as the 8mm x 4cm 80cm powerflex extreme was inserted into the patient.The device was able to track toward the lesion and cross the lesion without issue.The device was never put into an acute bend during this procedure and it did not kink during its use.After the balloon rupture, the device was removed without issue and remained intact during its removal from the patient.Information regarding the patient was requested but not provided, and the device was discarded and will not be returned for evaluation.

• Brand Name: POWERFLEX EXTREME 8X4 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 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14237450
• Report Number: 3009018440-2022-00008
• Device Sequence Number: 14645990
• Product Code: LIT
• UDI-Device Identifier: 20705032001943
• UDI-Public: (01)20705032001943(17)240731(10)82230363
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 04/28/2022

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: 07/31/2024
• Device Model Number: 4158040S
• Device Catalogue Number: 4158040S
• Device Lot Number: 82230363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 04/28/2022
• Date Device Manufactured: 08/31/2021
• 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: 9MM X 4CM 80CM POWERFLEX EXTREME PTA BALLOON; GE OMNIPAQUE CONTRAST
• Patient Sex: Unknown