MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS¿ INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Vascular Problem (4441); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported right femoral vein laceration could not be conclusively determined.

Event Description

Related manufacturer ref: 3008452825-2021-00551.The following was published in journal of arrhythmia, procedural outcome of lead explant and countertraction-assisted femoral lead extraction in thai patients with cardiac implantable electronic device infection by jirarat jiratham-opas md, et al: may 2021.A study was conducted aim to investigate the procedural outcome of countertraction-assisted transfemoral lead removal technique of cied infection in 35 (b)(6) patients.A right femoral vein laceration was noted in one patient after the completion of the procedure requiring surgical repair.No extensive surgery was required.During the procedure for the lead extraction, if the targeted lead could not be removed by simple manual traction, a femoral vein approach was proceeded with by placing two long sheaths into the right femoral vein.Doi: 10.1002/joa3.12574.

Manufacturer Narrative

Correction: h6.

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12888710
• MDR Text Key: 282041734
• Report Number: 3008452825-2021-00550
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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