MAUDE Adverse Event Report: MEDTRONIC VASCULAR MEDTRONIC 5F JL 3.5 DXTERITY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number DXT5JL35

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Diagnostic cardiac catheters kinked prior to use on patient.

• Brand Name: MEDTRONIC 5F JL 3.5 DXTERITY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC VASCULAR; 37a cherry hill drive; danvers MA 01923
• MDR Report Key: 12532039
• MDR Text Key: 273371998
• Report Number: 12532039
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DXT5JL35
• Device Catalogue Number: DXT5JL35
• Device Lot Number: 60294510
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA