MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407362

Device Problem Gas/Air Leak (2946)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

During device preparation for an atrial fibrillation procedure, a saline leak was noted from the hemostasis valve when flushed.Following insertion into the patient, air was aspirated from the hemostasis valve.The introducer was replaced and the procedure was completed with no adverse consequences to the patient.

Event Description

The event was noted during prep which is not a reportable event.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP¿ 45, 63 CM LENGTH, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15209810
• MDR Text Key: 299405519
• Report Number: 3005334138-2022-00469
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205573
• UDI-Public: 05414734205573
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

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 Model Number: 407362
• Device Catalogue Number: 407362
• Device Lot Number: 8487579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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 Age: 58 YR
• Patient Sex: Male