MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 7MM2CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48007002S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17220442 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the tip of a saber broke off as the tech was loading onto the wire.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.The malfunction was noted during prep.The catheter was not loaded.Force was not used at any time.

Manufacturer Narrative

The tip of a saber broke off as the tech was loading it onto the wire.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.The malfunction was noted during prep.The catheter was not loaded.Force was not used at any time.The product was returned for analysis.One non-sterile unit of saber 7mm x 2cm 90cm balloon catheter was received.Per visual analysis, the balloon had not been inflated or deflated and the distal tip of the balloon device was found separated.No other damages were noted in the device.Per microscopic analysis the separated edges showed evidence of elongation.Per the scanning electron microscopy (sem) analysis, the separated edges revealed evidence of plastic deformation such as elongations and frayed edges.These characteristics suggest that the device was subjected to stretching and/or pulling events that exceeded the material yield strength of the device prior to the separation.No other issues were noted.A device history record (dhr) review of lot 17220442 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip - separated - during prep¿ was confirmed through analysis of the returned device.The exact cause of the 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 with plastic deformation and frayed edges noted on the edges during analysis indicative of the use of excessive force.According to the safety information in the instructions for use ¿proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ 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 at this time.

• Brand Name: SABER 7MM2CM 90
• 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: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6770272
• MDR Text Key: 81921126
• Report Number: 9616099-2017-01296
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 48007002S
• Device Lot Number: 17220442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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