MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEXPRO 8MM4CM 135; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4400804X

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with lot 17491553 revealed no anomalies during the manufacturing and inspection processes.  the product is available for evaluation and testing; however, it has not been received to date. additional information will be submitted within 30 days of receipt.

Event Description

During the use of a powerflex pro balloon (8mm4cm 135), it was reported that under the normal operating pressure, the balloon was longitudinal separated in vascular lumen.  failed to normal expansion lesion.  there was no report of patient injury.The product will be returned for analysis.

Manufacturer Narrative

Complaint conclusion: during the use of a powerflex pro balloon (8mm4cm 135), it was reported that under the normal operating pressure, the balloon had a longitudinal separation in vascular lumen.  failed to normal expansion lesion.  there was no report of patient injury.Multiple attempts to gather additional information have been made and have been unsuccessful.  the device was not returned for analysis.A device history record (dhr) review of lot 17491553 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. the reported ¿balloon separated - in-patient (peripheral)¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Additional information and vessel characteristics were not provided.According to the instructions for use (ifu), ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.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.Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.Remove the vacuum (do not apply pressure) and carefully withdraw and remove the catheter.Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as a unit.¿ neither the dhr nor the information available suggests a design or manufacturing related cause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: POWERFLEXPRO 8MM4CM 135
• 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 avenue; miami lakes, FL 33014
• MDR Report Key: 6134463
• MDR Text Key: 61097062
• Report Number: 9616099-2016-00770
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 4400804X
• Device Catalogue Number: 4400804X
• Device Lot Number: 17491553
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/08/2016
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2016
• 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