MAUDE Adverse Event Report: CATH F6 ST+ PIG 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 533650S

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.A review of the manufacturing documentation associated with this lot# 17958605 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

The operator finished their angiogram and was about to perform left ventricular (lv) pressure check by using the 6f 110cm straight (st) pigtail (pig) 6 side holes (sh) supertoque plus angiographic catheter, so, one of the nurses was checking the tip to make sure that it was pig tail, however, hair was noted inside of the packet.There was no reported patient injury.The device will be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly d8,d9,g3,g4,g7,h1,h2,h3 and h6.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly g4,g6,h1,h2,h3 and h6.The operator finished their angiogram and was about to perform left ventricular (lv) pressure check by using the 6f 110cm straight (st) pigtail (pig) 6 side holes (sh) supertorque plus angiographic catheter, one of the nurses was checking the tip to make sure that it was a pig tail, however, hair was noted inside of the packet.The device was properly stored in the hospital cabinet.The hair was noted inside of the package.The integrity of the sterile pouch was not compromised.The procedure was completed by using another cordis pigtail.There was no reported patient injury.Two pictures were received for analysis.Additionally, the product label, a hair of unknown origin and the flex tip tray were returned for analysis.The actual product was not received for analysis.Per picture analysis, on the first picture attached, a unit inside a pouch is observed.It could not be determined if the pouch was opened.The second picture shows the unit assembled in the tray, which was located outside of the pouch and a foreign matter (seems like hair) can be observed in the tray.No other anomalies of the product can be noticed on the attached pictures.A product history record (phr) review of lot 17958605 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿packaging/pouch/box ~ foreign material - in sterile package¿ was confirmed.A hair was returned attached to the flex tip tray with a metallic clip.However, it is not possible to determine if this condition is related to the product manufacturing due to is not known whether the package was sterile when the hair was noted based on the picture provided.Per the instructions for use (ifu), which is not intended as a mitigation of risk, "per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿do not expose to organic solvents.Store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54oc (130of) may damage the catheter.¿ standard clinical practice calls for inspection of the device and packaging prior to use in the patient.If the user notes anything unusual, they are urged to discontinue use of the device and exchange for another.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: CATH F6 ST+ PIG 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11003127
• MDR Text Key: 222019869
• Report Number: 9616099-2020-04121
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032013352
• UDI-Public: 10705032013352
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 533650S
• Device Catalogue Number: 533650S
• Device Lot Number: 17958605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2020
• 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: CORDIS PIGTAIL