MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6INF PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534650S

Device Problem Partial Blockage (1065)

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

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18107364 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 6f straight pigtail 110cm 6 sideholes (sh) infiniti diagnostic catheter was used in a patient and had no side holes, only has an end hole.There were no complications encountered with the patient.The procedure was completed with another unknown product.The device was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was used in a aortography.The side holes were noticed to be missing by the user handling the device when the device was flushed after opening the pack of the product before using in the patient.The device was prepped according to the instructions for use (ifu).The device will be returned for evaluation.

Manufacturer Narrative

Section b5 and d10 corrected.

Event Description

As reported, a 6f straight pigtail 110cm 6 sideholes (sh) infiniti diagnostic catheter had no side holes, only had an end hole.The side holes were noticed to be missing by the user handling the device when the device was flushed after opening the pack of the product before using in the patient.The device was not used in the patient.The procedure was completed with another unknown pigtail catheter.There were no complications encountered with the patient.The device was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was used in a aortography.The device was prepped according to the instructions for use (ifu).The device will be returned for evaluation.

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, h6, and h10 complaint conclusion: as reported, a 6f straight pigtail 110cm 6 sideholes (sh) infiniti diagnostic catheter had no side holes, only had an end hole.The side holes were noticed to be missing by the user handling the device when the device was flushed after opening the pack of the product before using in the patient.The device was not used in the patient.The procedure was completed with another unknown pigtail catheter.There were no complications encountered with the patient.The device was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was used in an aortography.The device was prepped according to the instructions for use (ifu).The device was returned for analysis, one non-sterile unit of a cath f6inf pig 110cm 6sh was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.During the visual inspection, no damages were noted on the device as received.The distal tip was inspected, and no side holes were observed to be present on the device.The phr review for lot 18107364 was reviewed and no issues were noted that could be related to the reported complaint.The reported event by the customer as ¿catheter (body/shaft) ¿ no side holes ¿ during prep¿ was confirmed since analysis of the device observed that there were no side holes present.The product analysis suggests that the event experienced by the customer could be related to the manufacturing process.This event has been escalated via the risk management process and an investigation has been opened to address the issue.

• Brand Name: CATH F6INF 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: 16040372
• MDR Text Key: 306591499
• Report Number: 9616099-2022-06175
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 534650S
• Device Catalogue Number: 534650S
• Device Lot Number: 18107364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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: UNKNOWN PIGTAIL CATHETER; UNKNOWN PRODUCT
• Patient Sex: Male