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

Model 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	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A powerflex pro balloon catheter (bc) ruptured.Therefore it was replaced with a new balloon catheter and post-dilatation was performed.The procedure was completed successfully.There was no patient injury.After the stent deployment, a powerflex pro was inserted and inflated.However it burst.The target lesion was in the iliac artery.The patient¿s vessel level of tortuousness was unknown.The lesion was calcified.The rate of stenosis was unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17611211 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of calcification may have contributed to the reported event.According to 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 dhr 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
It was reported that a power flex pro balloon rupture.Therefore it was replaced with a new balloon catheter and post-dilatation was performed.The procedure was completed successfully.There was no patient injury.After the stent deployment, a power flex pro was inserted and inflated.However it burst.The target lesion was the both side of the iliac artery.The patient¿s vessel level of tortuousness was unknown.The lesion was calcified.The rate of stenosis was unknown.The product was clinically used and will not be returned for analysis.

• Brand Name: POWERFLEXPRO 7MM4CM 80
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6379928
• Report Number: 9616099-2017-00941
• Device Sequence Number: 675918
• Product Code: LIT
• UDI-Device Identifier: 20705032059692
• UDI-Public: 20705032059692
• Combination Product (Y/N): N
• PMA/510(K) Number: K112797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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 Model Number: 4400704S
• Device Catalogue Number: 4400704S
• Device Lot Number: 17611211
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2017
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1