MAUDE Adverse Event Report: ST. JUDE MEDICAL 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 05/28/2021

Event Type  Injury  

Manufacturer Narrative

One image was submitted for evaluation to product performance engineering; no device components were returned.The guidewire tip appeared to be bent in multiple locations and knotted.Visual inspection was based solely upon a review of the photograph provided.The device was not returned; however, the aforementioned damage to the guidewire is consistent with the reported guidewire withdrawal difficulty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.

Event Description

During a atypical flutter (afl) ablation procedure, the sheath guidewire became stuck in the right femoral vein.The procedure was continued with the guidewire left in the right femoral vein with no issues.At the end of the procedure, the physician cut the vein 2cm to reach the guidewire and it was removed.When the guidewire was removed, a knot was noted at the distal end of the guidewire.The patient remained stable throughout the procedure, and is currently in stable condition.There were no performance issues with any abbott devices.

• 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12007853
• MDR Text Key: 256444295
• Report Number: 3008452825-2021-00319
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206099
• UDI-Public: 05414734206099
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2021

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 Expiration Date: 12/31/2023
• Device Model Number: 408309
• Device Catalogue Number: 408309
• Device Lot Number: 7804361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2021
• 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): Required Intervention