MAUDE Adverse Event Report: CORDIS CORPORATION POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER; PTA CATHETERS (LIT)

Catalog Number 4400510S

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: guidewire (radifocus, terumo), guiding catheter (6f parent, medikit).(b)(6).Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, after the guidewire (radifocus, terumo) crossed the lesion, a powerflex pro 5mm 10cm 80 balloon catheter was delivered to the lesion and inflated, however, at the same time of the inflation, leakage of media was observed and it could not be inflated.Therefore, the balloon catheter was changed out to a new unknown balloon catheter.The procedure finished successfully.There was no report of patient injury.A guiding catheter (6f parent, medikit) was inserted, crossed and approached the lesion.The guidewire (radifocus, terumo) could not be crossed easily with heavy calcification.The target lesion was the left common femoral artery.The lesion was heavily calcified and mildly tortuous.The rate of stenosis was 95%.The product was stored, handled, and prepped according to the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product into the patient.The device did prep normally.It is unknown what contrast media was used.It is unknown what the contrast to saline ratio was.It is unknown what type and brand of inflation device was used.It is unknown if there was difficulty advancing the balloon catheter through the vessel or crossing the lesion.It is unknown if the balloon catheter was ever in an acute bend.The balloon catheter was removed easily and intact (in one piece) from the patient.The maximum inflation pressure is unknown.The device will not be returned for analysis.

Manufacturer Narrative

After the guidewire crossed the lesion, a powerflex pro 5mm x 10cm 80cm balloon catheter (bc) was delivered to the lesion and inflated; however, at the same time of the inflation, leakage of media was observed and it could not be inflated.Therefore, the balloon catheter was changed out to a new unknown balloon catheter.The procedure finished successfully.There was no report of patient injury.A guiding catheter was inserted, crossed and approached the lesion.The guidewire could not be crossed easily due to heavy calcification.The target lesion was the left common femoral artery.The lesion was heavily calcified and mildly tortuous.The rate of stenosis was 95%.The product was stored, handled, and prepped according to the instructions for use (ifu).There were no kinks or other damages noted prior to inserting the product into the patient.The device did prep normally.It is unknown what contrast media was used.It is unknown what the contrast to saline ratio was.It is unknown what type and brand of inflation device was used.It is unknown if there was difficulty advancing the balloon catheter through the vessel or crossing the lesion.It is unknown if the balloon catheter was ever in an acute bend.The balloon catheter was removed easily and intact (in one piece) from the patient.The maximum inflation pressure is unknown.The device was not returned for analysis.A device history record (dhr) review of lot 15981958 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 (peripheral)¿ and ¿balloon inflation difficulty-unable to inflate¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of heavy calcification, mild tortuosity and a rate of stenosis of 95% may have contributed to the reported event.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

Manufacturer Narrative

No device was returned and evaluated.

• Brand Name: POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5277658
• MDR Text Key: 33036856
• Report Number: 9616099-2015-00635
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 4400510S
• Device Lot Number: 15981958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR