MAUDE Adverse Event Report: CORDIS DE MEXICO CATH F6 ST+ AL I 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 533645

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

It was reported that the angiographic diagnostic catheter external layer detached from the catheter body and broken into small pieces inside the sterile box.There was no patient injury.

Manufacturer Narrative

A device history record (dhr) review could not be conducted as the sterile lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The supertorque angiographic diagnostic catheter external layer detached from the catheter body and broken into small pieces inside the sterile box.There was no patient injury.Multiple attempts were made without success to obtain additional information.One sterile diagnostic cardiology catheter cath f6 st+ al i 100cm was received for analysis inside of its original sterile pouch.Pouch was labeled/ identified as lot number 17270807; catalog number 533645.Per visual analysis, the strain relief of the unit was received completely peeled off from the catheter body and found broken into small pieces inside the sterile pouch.Also, a yellowish color condition was observed on the hub.No other anomalies found.The unit was submitted to ftir /tga analyses in order to determine, if possible, what type of deterioration occurred or to determine the assignable cause of the discoloration observed.Per ftir abstract, ¿ir data revealed that chemical structure and functional groups remain mostly unaltered on complaint unit, however ir bands do hint to a possible degradation, specifically, chain scission within the polymer.In addition tga data confirmed advanced degradation of catheter.This suggests a potential degradation of the material caused by an external source such as direct sunlight, humidity or excessive temperature, the exact mechanism however is unknown¿.Per analyses conclusion: ftir and tga analytical techniques were carried out over complaint unit; and results were compared against control sample in order to interpret differences to aid in determining the cause of degradation (strain relief) and discoloration (hub) observed in the complaint unit.Ftir analysis ruled out change in the chemical formulation used on body of complaint unit since characteristic ir absorption bands of polyamide were observed, however when spectra were compared, it was noticed an additional peaks around 1700 cm-1, that indicates advanced degradation in strain relief material affecting mainly the tertiary amine group and was observed as a slight increase in the absorption of bands from complaint unit.This condition suggests presence of oxidation on strain relief caused by an external agent such as sunlight, humidity, temperature, among others.The degradation of the material should be considered as the appearance of the peaks in the complaint sample, this indicates the change in molecular structure caused by oxidation process that induces chain scissions.In addition tga analysis over complaint sample reinforces the results of ftir analysis; where results show an advanced state of degradation directly affecting their thermal performance.Finally, the material alterations; discoloration, cracking and reduced thermal properties, are consistent with a type of photo-induced degradation, most probably linked to exposure, however the exact mechanism is unknown based solely on these analyses.Review of lot 17270807 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported ¿coating-separated - prior to use¿ was confirmed during analysis.However, the exact cause of the failure experienced by the customer could not be conclusively determined.However, based on the information provided, shipping/handling factors are likely contributors.As cautioned in the instructions for use: ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ 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: CATH F6 ST+ AL I 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 6202265
• MDR Text Key: 63219966
• Report Number: 9616099-2016-00813
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 533645
• Device Catalogue Number: 533645
• Device Lot Number: 17270807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2016
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• 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