MAUDE Adverse Event Report: ST. JUDE MEDICAL GUIDERIGHT GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number 404569

Device Problem Difficult to Insert (1316)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/27/2022

Event Type  Injury  

Event Description

Related manufacturing ref: 2030404-2022-00007.During the procedure, a fibrous material was noted on the guidewire as well as thrombus noted inside the catheter lumen.When attempting to insert the catheter into the blood vessel, resistance was noted.The guidewire was then advanced into the lumen.Upon removal of both the catheter and the guidewire, fibrous material was entwined with the guidewire.The lumen diameter was small, and a thrombus had formed inside the lumen.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One guideright guidewire was received for evaluation.The distal end of the guidewire was pulled to remove the guidewire from the catheter; resistance was noted due to a dried blood like substance (bls), however, the guidewire was able to be removed.There were multiple bends and dried bls throughout the guidewire.No fibrous material was noted.The guidewire outside diameter measurement was consistent with manufacturing specifications.No resistance or other functional anomalies were noted during guidewire insertion through a dilator from current inventory.The device was manufactured according to specifications as supported by the receiving inspection results.The cause of the reported guidewire insertion difficulty and ¿fibrous material entwined with the guidewire¿ remains unknown.

• Brand Name: GUIDERIGHT GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13457297
• MDR Text Key: 286126429
• Report Number: 3005334138-2022-00053
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K935170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 404569
• Device Lot Number: 9941438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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
• Patient Outcome(s): Other