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

Model Number 534650S

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/04/2022

Event Type  malfunction  

Event Description

As reported, there was a hair present in the ¿inner product¿ of a 6f infiniti ventricular straight pigtail sideholes 110cm diagnostic catheter.The issue was observed in the lsp custom bonded warehouse during inspection and at the time of pasting over labelling (inner and outer) procedure.The device was not used in the patient.There was no reported patient injury.The device was stored per instructions for use (ifu).Image review was completed and image one shows the.Uter box with label stating 6f 110cm infiniti pigtail catheter.The second image shows the tip of a pigtail catheter inside the sterile pouch.A foreign material, which looks like hair is noted inside the pouch.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18106106 presented no issues during the manufacturing process that can be related to the reported event.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.The product history review is expected but has not been completed.This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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: as reported, there was a hair present in the ¿inner product¿ of a 6f infiniti ventricular straight pigtail sideholes 110cm diagnostic catheter.The issue was observed in the lsp custom bonded warehouse during inspection and at the time of pasting over labelling (inner and outer) procedure.The device was not used in the patient.There was no reported patient injury.The device was stored per instructions for use (ifu).Images were provided and the device was returned for evaluation.Per picture analysis, picture one shows the outer label of an infiniti product; the following information can be read: catalogue: 534-650s, lot number# 18106106 and use by date 2025-03-31.The second picture shows a section of a pouch, and a foreign material could be observed.No other anomalies were observed in the images.Product evaluation: one sterile cath f6inf pig 110cm 6sh unit was received coiled for analysis inside a plastic bag.The device was unpacked to proceed with the product evaluation.During visual inspection, the unit was received in its sealed pouch.Previously a picture analysis was performed, and a foreign material was noted near the distal tip, during the physical review of the unit, no foreign material was detected, however, the unit was opened to thoroughly review the non-visible areas through the clear part of the pouch and an apparent hair/fiber/thread was noted below the cardboard near the distal tip.No other anomalies were noted during analysis.An ftir analysis was performed to determine the nature of the foreign material found inside the unit.As per preliminary results indicate according to the visual inspection through the vision system and the infrared spectrum, the material found is a hair.A product history review of lot 18106106 revealed no anomalies during the manufacturing and inspection processes that can be considered potentially related to the reported complaint.The reported event of ¿packaging/pouch/box ¿ foreign material - in sterile package¿ was confirmed during analysis of the returned device.As the exact cause of the event could not conclusively be determined the event was escalated per the risk management process and a risk assessment has been opened to further investigate 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: 15121974
• MDR Text Key: 297766518
• Report Number: 9616099-2022-05853
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032014397
• UDI-Public: 10705032014397
• 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
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 18106106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2022
• 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