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

Model Number	406137
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The fast-cath hemostasis introducer became detached at the side tubing.The patient reported liquid flowing in and on their neck right away.The fast-cath hemostasis introducer was removed.The patient specific information of patient identifier, age, or birthdate, weight and gender could not be collected due to rgdp -local regulation in (b)(6).
Additional Manufacturer Narrative
The fast-cath hemostasis introducer became detached at the side tubing.The patient reported liquid flowing in and on their neck right away.The fast-cath hemostasis introducer was removed without any interventions.Another fast-cath hemostasis catheter was used.Patient identifiers could not be collected due to (b)(6) local regulation.
Event or Problem Description
The fast-cath hemostasis introducer became detached at the side tubing.The patient reported liquid flowing in and on their neck right away.The fast-cath hemostasis introducer was removed without any interventions.Another fast-cath hemostasis catheter was used.Patient identifiers could not be collected due to (b)(6) local regulation.
Additional Manufacturer Narrative
The reported event of sideport tubing detachment was confirmed.The extension tubing had detached from the sideport of the hemostasis body and was not returned.The device met specifications prior to release from abbott manufacturing facilities as supported by a review of the device history record.Based on the received condition of the device and the information provided, the cause of the sideport tubing detachment remains unknown.The fast cath introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The fast cath introducer sheath instructions for use (ifu) cautions that the user should not attempt to insert a catheter having a distal tip or body larger than the introducer size indicted.

• 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: 7630837
• Report Number: 3005334138-2018-00182
• Device Sequence Number: 19298148
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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: 05/31/2020
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 6019909
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 08/22/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/20/2018; 09/04/2018
• 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