MAUDE Adverse Event Report: CORDIS CORPORATION INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 538453S

Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2024

Event Type  malfunction  

Event Description

As reported, a 4f 110cm, pigtail 145 degrees, 6-sidehole (sh) micro loop infiniti diagnostic catheter got stuck in the radial artery.It became "unstuck" and "doubled over itself and broke".The catheter did not break apart, however, the catheter kinked on itself and the.035in wire punctured out at the kink.There were no reports of patient injury.The device was kept in the cath lab.The access site and target site vessel were of normal anatomy.The device was removed properly.The device was torqued or ¿steered¿ by the hub.When withdrawing the device, the catheter had kinked, and when the.035 wire was advanced in, it exited at the kink (not the lumen).The catheter did not break apart.The catheter bent over on itself in the right brachial-cephalic artery.The device was properly stored.The patient had no issues and received an intervention via the same right radial approach.The catheter will be returned for evaluation.Per image review, the radiographic image appears to display a pigtail catheter in the right radial artery.Three kinked conditions are noted toward the distal end of the catheter.The most proximal kink has caused the distal end of catheter to fold over and point in an antegrade direction.A guidewire is seen protruding outside of the catheter at the proximal kink.Two additional kinked/bent conditions are noted towards the distal tip of the catheter.

Manufacturer Narrative

This device is available for analysis, but the 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6 as reported, a 4f 110cm, pigtail 145 degrees, 6-sidehole (sh) micro loop infiniti diagnostic catheter got stuck in the radial artery.It became "unstuck" and "doubled over itself and broke".The catheter did not break apart, however, the catheter kinked on itself and the.035in wire punctured out at the kink.There were no reports of patient injury.The device was kept in the cath lab.The access site and target site vessel were of normal anatomy.The device was removed properly.The device was torqued or ¿steered¿ by the hub.When withdrawing the device, the catheter had kinked, and when the.035 wire was advanced in, it exited at the kink (not the lumen).The catheter did not break apart.The catheter bent over on itself in the right brachial-cephalic artery.The device was properly stored.The patient had no issues and received an intervention via the same right radial approach.One image was submitted for analysis.It is a radiographic image of a guidewire and catheter over what appears to be a patient's right humerus.The catheter is folded over in four places at the distal portion of the right humerus.The guidewire appears to be sticking out of the body of the catheter at the most proximal fold.A non-sterile unit of catheter cath4f inf pig 145° mod 110cm 6sh was subsequently received for analysis.During visual inspection, the catheter did not present with any anomalies or damages to the hub, body or brite tip/distal tip that were visible to the naked eye.The apparent kink/bent condition near the brite tip is part the catheter shape.Amplified images of the brite tip/distal tip were taken.A puncture was noted near the last proximal sidehole, which presented with evidence of elongations on the outer surface and no scratch marks near the damaged area.The reported ¿catheter (body/shaft) ¿ kinked/bent¿ could not be confirmed by product evaluation or photo analysis.A kinked/bent condition was not observed during the product evaluation therefore, the folds noted in the image review likely illustrated a prolapsed condition.The reported ¿catheter (body/shaft)-withdrawal difficulty¿ could not be confirmed by product evaluation either.Withdrawal difficulty cannot be visualized in a still image and it cannot be evaluated in a laboratory environment due to the nature of the complaint.The reported event ¿catheter (body/shaft) ¿ puncture/cut¿ was confirmed.A puncture cut was noted near the last proximal sidehole.The evidence of elongations on the outer surface with no scratch marks near the damaged area is commonly caused by an interaction between the inner surface of the catheter and a sharp object or by mechanical damage.Based on the direction of the elongations, it seems the material near the puncture was torn by an interaction of the unit with a sharp object or mechanical damage from inside the device.The provided image suggests the guidewire punctured through the inner lumen of the catheter at one of the prolapsed sections.Procedurally related withdrawal difficulty may have caused the catheter to prolapse and attempts to advance the guidewire through the prolapse may have caused the wire to puncture through the catheter.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, and specifically the 4f (1.35 mm) infiniti® pigtail catheters: 1.Straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.2.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.¿ based on the available information, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: INFINITI
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14021 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18677973
• MDR Text Key: 336305870
• Report Number: 9616099-2024-00049
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 538453S
• Device Lot Number: 18247504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2023
• 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
• Treatment: UNKNOWN.
• Patient Sex: Male