MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, SMALL CURL, 8.5F; INTRODUCER, CATHETER

Model Number 408309

Device Problem Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/08/2021

Event Type  malfunction  

Event Description

During a premature ventricular contraction ablation procedure, the guidewire was knotted and became trapped in the femoral vein.While the guidewire was being advanced through the cannula, resistance was noted and eventually became lodged in the femoral vein.The cannula was removed, and a non-abbott short dilator was inserted via the guidewire.An extended incision was made at the puncture site and the guidewire was pulled out.Knots were noted at the distal end of the guidewire and the distal section was noted to be stretched after removing it from the patient.The procedure was postponed and the patient has been discharged from the hospital.

Manufacturer Narrative

One 8.5f agilis introducer guidewire was received for evaluation.The sheath and dilator were not received for evaluation.A non-abbott dilator was also returned.The device was returned due to patient insertion difficulties, a guidewire knot and surgical intervention.There was a knot at the distal end of the guidewire consistent with the reported event.The guidewire corewire had been fractured; both corewire sections remained attached to guidewire assembly.The guidewire outside diameter measurements were within specifications.The cause of the guidewire knot remains unknown; however, it was noted that artmt600078576 ver.Agilis nxt steerable introducer instructions for use (ifu) states ¿if resistance is met when advancing or withdrawing guidewire or introducer, determine cause and correct before continuing with this procedure.¿ the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the patient insertion difficulty remains unknown.The cause of the guidewire knot and corewire fracture is consistent with damage during use.

• Brand Name: AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, SMALL CURL, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 12143199
• MDR Text Key: 260728530
• Report Number: 3008452825-2021-00381
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: 05414734206099
• Combination Product (y/n): N
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 7713270
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1