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

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

During the procedure, insertion difficulties were noted when the guidewire was inserted into the superior vena cava (svc).The dilator was withdrawn into the sheath and the guidewire was advanced into the svc.The dilator was advanced back into position, withdrawing the guidewire to the tip and then withdrawing into the fossa, advancing the needle and guidewire into left atrium (la).Difficulty was noted advancing the sheath over the guidewire into the la.The sheath was removed and a second puncture was required to access the site and the procedure was completed with no consequences to the patient.

Manufacturer Narrative

One 8.5f agilis steerable introducer sheath was received for evaluation.The sheath distal tip had been bent and creased; no puncture or cut was noted.The sheath vacuum relief hole (vrh) had been stretched and bent.The sheath distal tip had been bent and creased; no puncture or cut was noted.A dilator from current inventory was inserted through the entire length of sheath with no resistance noted; however, a gap was noted at the dilator/sheath transition, consistent with the aforementioned sheath tip damage.No anomalies were noted during guidewire insertion through the dilator/sheath assembly.The cause of the sheath tip damage and subsequent additional puncture site remains unknown.

• 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: 14507809
• MDR Text Key: 296257942
• Report Number: 3008452825-2022-00427
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K061363
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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