MAUDE Adverse Event Report: CORDIS CORPORATION CATH NYLEX 4F PIG 110CM 8SH; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 526413

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/01/2018

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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when entering the 4f pig catheter (cath nylex 4f pig 110cm 8sh) in the introducer, the tip bent.When disposing it, the catheter separated in two.There was no reported patient injury.The product will not be returned for analysis.

Manufacturer Narrative

Correction to product code.

Manufacturer Narrative

Complaint conclusion: during an unknown procedure, when inserting the 4f pig catheter (cath nylex 4f pig 110cm 8sh) into the introducer, the tip bent.When disposing it, the catheter separated in two.There was no reported patient injury.No other information was provided.The device was not returned for analysis.A product history record (phr) review of lot 17664660 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 events reported as ¿brite tip/distal tip - catheters~kinked/bent - in patient¿ and ¿catheter (body/shaft) separated¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural/handling factors may have contributed to the reported events.As cautioned in the instructions for use (ifu), which is not intended as a mitigation ¿store in a cool, dark, dry place.Do not use if package is open or damaged.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.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ the phr review does not suggest that the events experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH NYLEX 4F PIG 110CM 8SH
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8055978
• MDR Text Key: 128791892
• Report Number: 9616099-2018-02510
• Device Sequence Number: 1
• Product Code: DTK
• 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,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 526413
• Device Catalogue Number: 526413
• Device Lot Number: 17664660
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1