MAUDE Adverse Event Report: CORDIS DE MEXICO POWERFLEX P3 F5 8X4 80; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 4208040S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

The product is being returned for analysis, however, not yet received.Additional information will be submitted within 30 days of receipt.

Event Description

Prior to use, the shaft of a powerflex p3 (f5 8x4 80) snapped in half prior to use.There was no patient injury as the device was not used in patient.The product will be returned for analysis.The device was stored per instructions for use (ifu).There were no anomalies noted when the product was removed from the package. the device was removed from the packaging as per ifu and the product was handled per ifu. there was no excessive force used during the prepping of the device. no pictures are available.

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.   additional information will be submitted within 30 days of receipt. .

Manufacturer Narrative

The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.  additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Complaint conclusion: prior to use, the shaft of a powerflex p3 (f5 8x4 80) snapped in half prior to use.There was no patient injury as the device was not used in patient.The device was stored per instructions for use (ifu).There were no anomalies noted when the product was removed from the package.  the device was removed from the packaging as per ifu and the product was handled per ifu.  there was no excessive force used during the prepping of the device.   a non-sterile powerflex p3 f5 8x4 80 catheter was received for analysis coiled inside a plastic bag.The balloon was received deflated.The shaft was separated at its distal section, just close to the balloon.No other anomalies were observed.Sem analysis results showed that the separated sections of powerflex outer member, presented elongations and frayed edges.These characteristics presented evidence as a product of an application of a tension force that induced the separation.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17567301 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. the reported ¿body/shaft - separated¿ was confirmed through analysis of the returned device.The exact cause of the body/shaft separation could not be determined during analysis.Based on the information available for review, handling factors may have contributed to the separation as evidenced by elongations and frayed edges on the catheter body during sem analysis.According to the instructions for use (ifu), ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: POWERFLEX P3 F5 8X4 80
• 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: 6383943
• MDR Text Key: 69274046
• Report Number: 9616099-2017-00943
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4208040S
• Device Catalogue Number: 4208040S
• Device Lot Number: 17557301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/10/2017
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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