MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿LUMA-CATH¿ FIXED CURVE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-80937

Device Problem Difficult to Insert (1316)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/27/2022

Event Type  Injury  

Event Description

Related manufacturing ref: 3005334138-2022-00053.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 decapolar, inquiry luma-cath fixed curve diagnostic catheter was received for evaluation.A stock guidewire was inserted into the catheter with no anomalies noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Additional information received from the customer confirmed the fibrous material was only noted on the guidewire.

• Brand Name: INQUIRY¿LUMA-CATH¿ FIXED CURVE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13457387
• MDR Text Key: 288187920
• Report Number: 2030404-2022-00007
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991878
• 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: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IBI-80937
• Device Lot Number: 8067004
• 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
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 03/08/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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
• Treatment: GUIDERIGHT GUIDEWIRE.
• Patient Outcome(s): Other