MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿TRIO INTRODUCER, 10F, ACT; INTRODUCER, CATHETER

Model Number	406963
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Following insertion of the introducer, air entered the hemostasis valve while aspirating blood.The device was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 10f fast-cath trio introducer sheath, adaptor and dilator were received for evaluation.No visual anomalies were noted.The sheath passed pressure and aspiration leak testing with no anomalies observed.Microscopic inspection of the hubs and seals revealed no anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported leak remains unknown.

• Brand Name: FAST-CATH¿TRIO INTRODUCER, 10F, ACT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7962092
• Report Number: 3005334138-2018-00364
• Device Sequence Number: 201328
• Product Code: DYB
• UDI-Device Identifier: 05414734204057
• UDI-Public: 05414734204057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 04/30/2021
• Device Model Number: 406963
• Device Lot Number: 6434812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1