MAUDE Adverse Event Report: CORDIS CORPORATION CATH F4 INF JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.One picture of a diagnostic catheter of cath f4 inf jr 4 100cm was received attached to complaint, case-(b)(4).Per picture analysis, it was observed a puncture/cut condition on the catheter body.No other damages were observed on the picture provided.The complaint reported by the customer as ¿catheter (body/shaft)- puncture/cut - during prep ¿was confirmed due to the observed damage condition of unit on the attached picture.However, the cause of the puncture/cut condition observed cannot be conclusively determined based on the pictures visual analysis sole information provided.Pictures review do not suggest that the reported failure could be related to the manufacturing process.Procedural/ handling factors might have contributed to the failure as reported.Therefore, no actions will be taken at this time.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

Before use in the patient a 4f jr 4 infiniti catheter was leaking.There was no patient injury and the device will be returned.A photograph provided shows a puncture of the device.The device prepped following ifu instructions.Additional procedural details were requested but was not available.

Manufacturer Narrative

During prep, a 4f jr 4 infiniti catheter was noted to be leaking.There was no patient injury reported, the device was not used in the patient.The device was prepped according to the instructions for use (ifu).Multiple attempts were made without success to obtain the device and additional information.The device was not returned for analysis.One picture of a cath f4 inf jr 4 100cm was received.Per picture analysis, a puncture/cut condition was noted on the catheter body.No other damages were noted in the picture provided.A product history record (phr) review of lot 17813076 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 ¿catheter (body/shaft)- puncture/cut - during prep¿ was confirmed due to the damaged condition of device noted in the received picture.However, the cause of the puncture/cut condition cannot be conclusively determined based on the visual analysis of the picture provided.Storage and procedural/handling factors may have contributed to the event as reported.Per the instructions for use, 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 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.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.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ neither the phr review nor the available information suggest that the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken.

• Brand Name: CATH F4 INF JR 4 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8345245
• MDR Text Key: 139346759
• Report Number: 9616099-2019-02721
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032014615
• UDI-Public: 20705032014615
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 538421
• Device Lot Number: 17813076
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1