MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEXPRO 7MM4CM 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4400704S
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A powerflex pro percutaneous transluminal angioplasty (pta) balloon catheter (7mm x 4cm x 80cm) advanced to the lesion and inflated; however, it ruptured at six atmospheres (atm).There was no reported patient injury.The lesion was the left common femoral artery with stenosis.The powerflex pro balloon catheter was removed from the patient.It was replaced with a new same size non-cordis balloon catheter and the procedure was completed.Initially, a contralateral approach was made from the right inguinal region with a 6f guiding sheath.A guidewire (0.035) crossed the lesion and a cutting balloon catheter (5mm x 2cm) was inserted and inflated.The product was not returned for analysis.A product history record (phr) review of lot 17627889 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 of stenosis may have contributed to the reported event.Damage to balloon material may occur when attempting to cross a stenosed vessel.It is likely during this attempt to cross the damage occurred; however, 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 ¿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 event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, a powerflex pro pta balloon catheter (7mm4cm 80) advanced to the lesion and inflated; however, it ruptured at 6-atmospheres oressure (atm).There was no reported patient injury.The powerflex pro balloon catheterwas removed from the patient body.Then, it was replaced with a new same size non-cordis balloon catheter and the procedure was completed.The lesion was the left common femoral artery with stenosis.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is none.Initially, a contralateral approach was made from the right inguinal region with a 6f guiding sheath.A guidewire (0.035) crossed the lesion and a cutting balloon catheter (5mm*2cm) was inserted and inflated.The device was prepped according to instructions for use (ifu).The device was prep normally.The same indeflator was used successfully with other devices.The balloon did not inflate normally as it was ruptured.There was a leakage noted from the balloon.The catheter was not torqued against resistance.There were no kink/bent noted after the device was removed from patient.There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.There is no procedural film/cd available for review.The device will not be returned for analysis as the device was discarded in the hospital.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8707945
• Report Number: 9616099-2019-03027
• Device Sequence Number: 1993051
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: 20705032059692
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 11/30/2019
• Device Catalogue Number: 4400704S
• Device Lot Number: 17627889
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1