MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX EXTREME 6X4 80CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4156040S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was not returned for analysis.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6mm x 4mm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured upon initial inflation.Upon inflation to 3 atmospheres (atm), the balloon ruptured.There was no reported patient injury.The device was stored and was prepped according to instructions for use (ifu).There was no calcification or stent present.The lesion was a 90% focal stenosis of the juxtapose anastomosis of an end-stage renal patient.The device will not be returned for evaluation as it was already discarded.
Event or Problem Description
As reported, a 6mm x 4mm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured upon initial inflation.Upon inflation to 3 atmospheres (atm), the balloon ruptured.There was no reported patient injury.The device was stored and was prepped according to instructions for use (ifu).There was no calcification or stent present.The lesion was a 90% focal stenosis of the juxtapose anastomosis of an end-stage renal patient.There were no difficulties noted during prep.A half saline/half contrast ratio was used.A non cordis inflation device was used and it was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve nor while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The target vessel had 90% stenosis, no calcification, and no tortuosity.The product was removed intact (in one piece) from the patient.The device will not be returned for evaluation as it was already discarded.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: a2, a3, a4, b5, d10, e3, g3, g6, h1, h2, h3, h6, h8, and h10 complaint conclusion: as reported, a 6mm x 4mm x 80cm powerflex extreme percutaneous transluminal angioplasty (pta) balloon catheter ruptured upon initial inflation.Upon inflation to three atmospheres (atm), the balloon ruptured.There was no reported patient injury.The device was stored and was prepped according to instructions for use (ifu).There was no calcification or stent present.The lesion was a 90% focal stenosis of the juxtapose anastomosis of an end-stage renal patient.There were no difficulties noted during prep.A half saline/half contrast ratio was used.A non-cordis inflation device was used, and it was used successfully with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve nor while inserting the balloon through the guide catheter.The catheter was never in an acute bend.The target vessel had 90% stenosis, no calcification, and no tortuosity.The product was removed intact (in one piece) from the patient.The device was not returned for evaluation as it was already discarded.A product history record (phr) review of lot 82212704 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.The intended procedure was an angioplasty of a 90% focal stenosis of the juxtapose anastomosis fistula.Arteriovenous fistulas are often scarred and fibrous in nature and often resistant to balloon expansion increasing the likelihood of damage to the balloon.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.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 12161992
• Report Number: 9616099-2021-04707
• Device Sequence Number: 17347525
• Product Code: LIT
• UDI-Device Identifier: 20705032001752
• UDI-Public: 20705032001752
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 12/31/2023
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Device Lot Number: 82212704
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GE OMNIPAQUE 350MG/ML; MERIT BASIX INDEFLATOR
• Patient Age: 74 YR
• Patient Weight: 185