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

Model Number	533650S
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11003127
• Report Number: 9616099-2020-04121
• Device Sequence Number: 3814141
• Product Code: DQO
• UDI-Device Identifier: 10705032013352
• UDI-Public: 10705032013352
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/21/2020; 01/29/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 01/15/2021; 02/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS PIGTAIL