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

Model Number	406137
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The tubing of the fast-cath hemostasis introducer detached.The device was easily removed.Administration of cordarone and loxen medication was stopped and a slight increase of pressure in the patient was noticed.An emergency peripheral line was placed to restore medication administration.
Additional Manufacturer Narrative
The reported event of the detached sideport tubing was confirmed.The results of the investigation concluded the extension tubing had detached from the sideport of the hemostasis body.The investigation revealed traces of an adhesive ring around the sideport tubing at the location where the hemostasis body met the tubing.Based on the location of the adhesive ring, it was determined that the stopcock tubing was fully inserted into the sideport as required per the manufacturing procedure the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the detached sideport remains unknown.The fast-cath introducers instructions for use (ifu) recommends the user advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7927257
• Report Number: 3005334138-2018-00346
• Device Sequence Number: 11275802
• Product Code: DYB
• UDI-Device Identifier: 05414734012751
• UDI-Public: 05414734012751
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914090
• 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): 01/30/2019

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: 04/30/2020
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 6007533
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention