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

Model Number	406963
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	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During the procedure a sideport detachment occurred.The sheath set was replaced to continue the procedure.There were no adverse patient consequences.
Additional Manufacturer Narrative
One 10.5f fast-cath trio introducer sheath was received for evaluation.The sheath tubing had been detached from the sheath hub.Dissection of the sheath hub and visual inspection of the sheath tubing revealed all components were present and met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing detachment is consistent with damage during use.
Event or Problem Description
The irrigation tubing detached from the sheath hub, not the sideport as previously reported.

• 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: 9632842
• Report Number: 3005334138-2020-00030
• Device Sequence Number: 2800387
• Product Code: DYB
• UDI-Device Identifier: 05414734204057
• UDI-Public: 05414734204057
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061015
• 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): 04/28/2020

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: 406963
• Device Catalogue Number: 406963
• Device Lot Number: 6621576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1