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

Model Number	406104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the procedure, the sheath broke off from the hub inside the patient's femoral artery.The device was retrieved using a snare.The patient was stable.
Additional Manufacturer Narrative
One 6f fast-cath introducer sheath was received for evaluation.The sheath had been torn and separated.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage is consistent with damage during use.

• 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: 9179495
• Report Number: 3005334138-2019-00545
• Device Sequence Number: 3643304
• Product Code: DYB
• UDI-Device Identifier: 05414734008242
• UDI-Public: 05414734008242
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 406104
• Device Catalogue Number: 406104
• Device Lot Number: 6964398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/29/2019
• 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: Required Intervention
• Patient Age: 14 YR