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

Model Number 4156040S

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for analysis. a review of the manufacturing documentation associated lot 17532601 revealed no anomalies during the manufacturing and inspection processes that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that during the procedure a 6 x 40 mm powerflex extreme percutaneous transluminal angioplasty (pta) dilation catheter was inflated to 16 atm, deflated, repositioned and inflated once more to 6 atm, when it ruptured.The rupture occurred in the juxta anastamosis of a fistula.The powerflex pta was exchanged for a non-cordis balloon and the patient was successfully treated without further incident.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly: date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes.  during the procedure, a 6 x 40 mm powerflex extreme percutaneous transluminal angioplasty (pta) dilation catheter was inflated to sixteen atmospheres (16 atm), deflated, repositioned and inflated once more to 6 atm, when it ruptured.The rupture occurred in the juxta anastamosis of a fistula.The powerflex pta was exchanged for a non-cordis balloon and the patient was successfully treated without further incident.The lesion was not noticeably calcified.The rate of stenosis was 60%.The product was stored and handled according to the instructions for use (ifu).There were no anomalies noted when the device was taken out of the package.The device was prepped per the instructions for use (ifu).There were no anomalies noted during prep.The device prepped normally.There were no difficulties removing the product from the hoop.There were no difficulties removing the protective balloon cover.There were no difficulties removing the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The contrast media brand used was ge omnipaque.The contrast to saline ratio was 50/50.The inflation device was bard presto.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve.There was no resistance/ friction while inserting the balloon through the guide catheter.There was no difficulty advancing the balloon catheter through the vessel.There was no difficulty crossing the lesion.The device was not in an acute bend.The balloon catheter was easily removed from the vessel, from the sheath, from the rhv (rotating hemostatic valve), from the guidewire, from the guide catheter.The product was removed intact (in one piece) from the patient.The device was not returned for analysis.  the reported ¿balloon burst-at/below rbp (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics (fistula with 60% stenosis) may have contributed to the reported event.According to 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.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.

• Brand Name: POWERFLEX EXTREME 6X4 80CM
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6215438
• MDR Text Key: 63627203
• Report Number: 9616099-2016-00819
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 4156040S
• Device Catalogue Number: 4156040S
• Device Lot Number: 17532601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/05/2016
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1