MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH TRIO HEMOSTATIS INTRODUCER CATH-LOCK INTRODUCER; INTRODUCER, CATHETER

Model Number	406962
Medical Device Problem Codes	Fluid/Blood Leak (1250); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturing ref: 3005334138-2021-00563.During a paroxysmal supraventricular tachycardia (psvt) ablation procedure, an air leak occurred.After placing the sheath into the patient and prior to inserting catheters into the sheath, air was aspirated into the syringe that connected to the extension port of the sheath.Several aspirations were attempted but the air remained.The sheath set was replaced with a device from the same lot number, and the same issue occurred.The second sheath was replaced and the procedure was completed with no adverse consequences to the patient.No additional femoral vein puncture was required for replacing the sheath.
Additional Manufacturer Narrative
Correct code: h6 gas leak.

• Brand Name: FAST-CATH TRIO HEMOSTATIS INTRODUCER CATH-LOCK INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12391873
• Report Number: 3005334138-2021-00562
• Device Sequence Number: 19847634
• Product Code: DYB
• UDI-Device Identifier: 05414734204040
• UDI-Public: 05414734204040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 406962
• Device Catalogue Number: 406962
• Device Lot Number: 6618110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FAST-CATH TRIO¿ INTRODUCER; FAST-CATH TRIO¿ INTRODUCER