MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534550S

Device Problem Difficult to Remove (1528)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18091512 presented no issues during the manufacturing process that can be related to the reported event.As reported, at the time of removing a 5f straight pigtail 6 side holes (sh) infiniti catheter to change to another unknown catheter it was stuck in the non-cordis guide sheath and did not come out easily.The procedure was performed and completed without any complications and the patient came out fine.No additional intervention was required to prevent patient injury.The device was stored, handled, and prepped according to the instructions for use (ifu).The intended procedure was cardiac catheterization with aortogram for angina pectoris.There were no anomalies noted when removed from the package nor prior to inserting the product the product into the patient.There was no excessive torquing required.A product history record (phr) review of lot 18091512 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- withdrawal difficulty - through sheath¿ could not be confirmed.Compatibility issues between the infiniti catheter and the non-cordis guiding sheath may have contributed to the reported event.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, ¿the following specifications are identified on the catheter hub: 1.Maximum pressure rating (psi) 2.Catheter outer diameter (f) 3.Catheter length (cm) 4.Maximum guidewire diameter (in.) the color of the hub printing indicates the catheter french size as follows: 4f (1.35 mm) red 5f (1.65 mm) grey 6f (2.0 mm) green 7f (2.3 mm) orange 8f (2.7 mm) blue¿ 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 preventative or corrective actions will be taken at this time.

Event Description

As reported, at the time of removing a 5f straight pigtail 6 side holes (sh) infiniti catheter to change to another unknown catheter it was stuck in the non-cordis guide sheath and did not come out easily.The procedure was performed and completed without any complications and the patient came out fine.No additional intervention was required to prevent patient injury.The device was stored, handled, and prepped according to the instructions for use (ifu).The intended procedure was cardiac catheterization with aortogram for angina pectoris.There were no anomalies noted when removed from the package nor prior to inserting the product the product into the patient.There was no excessive torqueing required.The device was discarded and will not be returned for evaluation.

• Brand Name: CATH F5 INF PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15840375
• MDR Text Key: 304594653
• Report Number: 9616099-2022-06119
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 534550S
• Device Catalogue Number: 534550S
• Device Lot Number: 18091512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Date Device Manufactured: 03/02/2022
• 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: 0.35 TEFLON-COATED GUIDE SHEATH; ANOTHER UNKNOWN CATHETER
• Patient Age: 78 YR
• Patient Sex: Female