MAUDE Adverse Event Report: CORDIS CORPORATION CATH NYLEX 5F PIG TR 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 526530

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/04/2019

Event Type  malfunction  

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 complaint.This device is available for analysis but the final engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during the injection of the contrast product with an automatic injector (40cc to 20cc/second, maximum pressure 723 psi) to perform a pulmonary angiography, the 5f pigtail catheter (cath nylex 5f pig tr 65cm 8sh) broke at 4cm from the base which caused a delay in managing the patient.The device was received in two pieces.(b)(6) confirmed that the hub had separated from the body shaft of the catheter.

Manufacturer Narrative

Complaint conclusion: during an unknown procedure, the 5f pigtail catheter (cath nylex 5f pig tr 65cm 8sh) broke at 4cm from the base while using an automatic injector (40cc to 20cc / second, maximum pressure 723 psi) to perform a pulmonary angiography, which caused a delay in managing the patient.No other information was reported.The device was returned for analysis.A non-sterile cath nylex 5f pig tr 65cm 8sh diagnostic catheter was received for analysis coiled inside a plastic bag.Per visual analysis, the hub was found separated from the body shaft of the catheter.No other anomalies were noted.Cross-sectioned analysis was performed on the received separated luer hub to inspect the molded condition inside of the hub.Remnants of the body shaft in the walls of the luer hub were noted.Per microscopic analysis, of the cross-sectioned nylex 5f luer hub and the separated body shaft, evidence of elongations and body diameter reduction as well as material transference on the remnants of the body shaft were found inside the luer hub.Also, remnants of the strain relief inside the luer hub were confirmed through the scanning magnification.The body shaft material transference inside the separated luer hub suggests that the device was molded on the correct position at a certain time.The outer diameter (od) of the catheter close to the proximal area was measured and the results were found within specification.A product history record (phr) review of lot 17722034 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿luer hub ¿ catheters-separated - during use¿ was confirmed.However, the exact cause of the luer hub separated condition could not be conclusively determined during the analysis.Evidence of elongations due to body diameter reduction as well as material transference were noted per the remnants of the body shaft found inside the luer hub.Also, remnants of the strain relief inside the luer hub were found.Analysis results do not suggest that this damage is related to the manufacturing process of the device since the body shaft material transference inside the separated luer hub suggests that the device was molded on the correct position at a certain time.Therefore, handling process and /or procedural factors may have contributed to the luer hub separation.As per the instructions for use (ifu), which is not intended as a mitigation, ¿specifications: the following specifications are identified on the catheter hub: maximum pressure rating (psi), catheter outer diameter (f), catheter length (cm), maximum guidewire diameter (in.).Indications: cordis catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.Warnings: discard catheters after one procedure.Structural integrity and/or function may be impaired through reuse or cleaning.All parts are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.Do not expose to organic solvents.Do not use with ethiodol or lipiodol contrast media, or other such contrast media which incorporates the components of these agents.Do not exceed maximum pressure rating printed on product label and hub.Precautions: store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.¿ neither the product analysis nor the phr review suggests that the reported event could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

• Brand Name: CATH NYLEX 5F PIG TR 65CM 8SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8590821
• MDR Text Key: 144416635
• Report Number: 9616099-2019-02906
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032010747
• UDI-Public: 20705032010747
• Combination Product (y/n): N
• PMA/PMN Number: K971646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 526530
• Device Catalogue Number: 526530
• Device Lot Number: 17722034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTOMATIC INJECTOR; AUTOMATIC INJECTOR