MAUDE Adverse Event Report: ANGIOS CLASSIC ANGIOGRAPHIC CATHETER KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	ANG4 - 0040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used in treatment, the device was not returned for analysis, therefore, the clinical observation could not be confirmed.The investigation was focused on a review of product documentation.However, no information is available.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure for (angios catheter, in-process and final inspection): visual inspection; hub: using syringe, attach syringe to hub and blow air through sheath to verify lumen is not blocked.Strain relief: properly applied and no excessive glue.Proper attachment without gaps.Body: run the entire length of the catheter between your fingers and feel for any imperfections.Visually check for discoloration spots.Per ifu procedure carefully remove the catheter from the package by grasping the hub and slowly withdrawing it from the package.If resistance is felt when removing the guidewire from the catheter, determine the cause by fluoroscopy and remove the guidewire and catheter as a unit to prevent potential damage to the vessel wall.Pigtail catheters.Pigtail catheters are fitted with a straightener.Slide straightener forward until pigtail is straight.Place catheter tip on guidewire and retract the straightener by pulling on the straightener tab.No further follow-up is required.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.
Event or Problem Description
It was reported that during a diagnostic procedure on the patient, diagnostic catheter ang4-0040 was separated from the cannula, without any effort on the part of the doctor.No known patient harm.No additional information available as the case was not recorded by the hospital staff.

• Brand Name: ANGIOS CLASSIC ANGIOGRAPHIC CATHETER KIT
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12424284
• Report Number: 1035166-2021-00103
• Device Sequence Number: 14401449
• Product Code: DQO
• UDI-Device Identifier: 00885672101893
• UDI-Public: 00885672101893
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K092118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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: 01/03/2021
• Device Model Number: ANG4 - 0040
• Device Catalogue Number: ANG4 - 0040
• Device Lot Number: DP-09669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• 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