MAUDE Adverse Event Report: CORDIS DE MEXICO CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532598C

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

This device has been returned 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 during an aortic stent procedure, the catheter broke in the area before the markers, at the beveled extremity of a non-cordis introducer.The catheter was used with a 035" non-cordis guide.The operator of the device was able to recover the catheter with a urologic clamp.Prior to stent deployment, contrast was injected to better see the position in the vessel.The arteries were tortuous and calcified.There were no reported consequences to the patient.There were no specific treatments done following the reported event.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported event.

Manufacturer Narrative

It was reported that during an aortic stent procedure, the catheter broke in the area before the markers, at the beveled extremity of a non-cordis introducer.The catheter was used with a.035¿ non-cordis guidewire.The operator of the device was able to recover the catheter with a urologic clamp.Prior to stent deployment, contrast was injected to better see the position in the vessel.The arteries were tortuous and calcified.There were no reported consequences to the patient.There were no specific treatments done following the reported event.A non-sterile unit of cath mb 5f pig 65cm 8sh was received inside of a plastic bag.The catheter was received in two parts.24.5 cm from distal section was observed separated from the catheter.20 marker bands were observed and three marker bands were observed moved from their original place.Od/id was measured near the separated areas and results were found within specification.The catheter was inspected under vision system and elongations were observed on the separation areas.A meeting was held with pet team and it was concluded that a sem analysis must be required to determine the probably separation cause.Sem analysis was required to determine the cause of the separation and results showed that the distal and proximal sections of the rupture presented evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceeds the material yield strength prior to the separation.No other issues were noted during sem analysis.Review of lot 17565300 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The event reported by the customer as ¿catheter (body/shaft)/ separated - in patient¿ was confirmed due to the condition in which the catheter was received.The cause of the event experienced by the customer could not be conclusively determined.However, procedural factors may have contributed to the reported event as evident by elongations which could be attributed to tensile forces.According to the product instructions for use, manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter.Furthermore, if resistance is felt during manipulation, determine the cause of resistance before proceeding and confirm the catheter positioning under high quality fluoroscopic observation.Neither the device history record review nor the product analysis suggests that the event is related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH MB 5F PIG 65CM 8SH
• 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 ave; miami lakes, FL 33014
• MDR Report Key: 6085095
• MDR Text Key: 59350538
• Report Number: 9616099-2016-00707
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 17565300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/14/2016
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/01/2016; 12/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2016
• 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