MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 451513H0

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Event Description

As reported, the side of a 5f tempo berenstein (ber) 0.038in x 100cm diagnostic catheter ripped and twisted while in the patient's body.There was no reported patient injury.The device is expected to be returned for analysis.

Manufacturer Narrative

The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the side of a 5f tempo berenstein (ber) 0.038in x 100cm diagnostic catheter ripped and twisted while in the patient's body.After insertion into the left femoral artery, the catheter ripped approximately midway from the tip.The catheter was safely removed from the patient.There was no reported patient injury.Four pictures related to the reported failure were submitted for review.Picture #1 shows the inner label of the product, and the following information can be read: lot# 18199504, catalogue# 451-513h0 and use by date 2026-03-31.Pictures #2,3 & 4 show the catheter coiled and a section is twisted.Bloody residue could be noticed.No other anomalies of the product were noted during the photo analysis.The reported ¿catheter (body/shaft)-puncture /cut¿ was not confirmed, however a twisted condition was observed.The root cause of the failure reported by the customer could not be conclusively determined as part of the picture evaluation however, excessive torquing is a likely cause.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.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventive or corrective actions will be taken at this time.

• Brand Name: TEMPO
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18073561
• MDR Text Key: 327427329
• Report Number: 9616099-2023-06625
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032008440
• UDI-Public: 10705032008440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973401
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 451513H0
• Device Lot Number: 18199504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2023
• 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.