MAUDE Adverse Event Report: CORDIS CORPORATION CATH 5F INFINITI TL JR4.0 100C; DIAGNOSTIC CARDIOLOGY CATHETER (DQO)

Catalog Number 534521T

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, an infiniti catheter tip appeared to show signs of shearing once the wire was passed through it and the catheter was being flushed.There was no patient injury as the device was not clinically used.No excessive force was used at any time.The procedure was completed with a same catheter from a different lot.Attempts to gather further information were unsuccessful.One non-sterile unit of infiniti cath f5 inf jr 4 100cm was received coiled inside a plastic bag.Per visual analysis, kinked conditions were found on catheter body at 18.5 cm, 25 cm, 30cm, 39 cm, 48 cm and 58.35 cm.From catheter distal end.Also, the brite tip was received damaged.No other issues were found.The catheter od and id were measured near the kinked condition and were found within specification.The sample was analyzed under the vision system and was also sent to sem station.Sem results showed that the tip presented evidence of elongations.These deformations found on the tip of the sample could be related to a deformation induced by an object during the plastic state of the tip.No other anomalies were found during sem analysis.Dsc and tga analyses were carried out over a tip from a diagnostic catheter, which was received with noticeable damage (presumably melted).Dsc analysis revealed that the damaged tip has a thermoplastic behavior which means that it is capable to recover its properties after heat and reheat.In addition, it was demonstrated that it requires approximately 160°c to induce a phase change in the material from solid to rubbery state.Tip testing was performed and was unable to reproduce the event.Finally, tga test was executed in order to evaluate the thermal stability of the material revealed that the sheared tip has a comparable performance to that observed in the control sample.No change in the material performance was observable in the white brite tip received with damage.Review of lot 17065842 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported event by the customer of ¿brite tip/distal tip / frayed/split/torn (cardiovascular)¿ was confirmed as the condition as the product was received.The cause of the events experienced by the customer, as well as, the kink conditions found could not be conclusively determined.Clinical factors contributing to the damaged tip could not be determined.According to the product instructions for use (ifu), users are cautioned to prevent damage to the catheter tip during removal from the package, to grasp the hub and withdraw the catheter carefully.Neither the dhr nor the product analysis suggests that the reported event could be related to the design manufacturing process.Therefore, no corrective and preventive actions will be taken.

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.

Event Description

When an infiniti catheter was being flushed, it was reported that the brite tip section of the diagnostic catheter appeared to show signs of shearing once wire was passed through it.There was no patient injury as the device was not clinically used.No excessive force was used at any time.The procedure was completed with a same catheter from different lot.

Manufacturer Narrative

(b)(4).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.

• Brand Name: CATH 5F INFINITI TL JR4.0 100C
• Type of Device: DIAGNOSTIC CARDIOLOGY CATHETER (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4551325
• MDR Text Key: 13442079
• Report Number: 9616099-2015-00087
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 534521T
• Device Lot Number: 17065842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Date Device Manufactured: 08/04/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1