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

Model Number	406124
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
While removing the catheters post procedure from the groin, the fast-cath hemostasis introducer ripped.Part of the device was still in the patient but able to be removed because the catheter was still in the patient.
Additional Manufacturer Narrative
Product evaluation: the reported event of "the fast-cath hemostasis introducer ripped" could not be confirmed.The results of the investigation are inconclusive since the device was not received in the product performance engineering lab for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.The fast-cath introducer instructions for use (ifu) cautions the user to not attempt to advance or withdraw guidewire if resistance is felt.Use fluoroscopy to determine cause.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: 7608457
• Report Number: 3005334138-2018-00164
• Device Sequence Number: 1695132
• Product Code: DYB
• UDI-Device Identifier: 05414734014052
• UDI-Public: 05414734014052
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: No Information
• Device Expiration Date: 12/31/2020
• Device Model Number: 406124
• Device Catalogue Number: 406124
• Device Lot Number: 6288956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 06/16/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 49