MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7 F; INTRODUCER, CATHETER

Model Number	406702
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer related ref: 3005334138-2019-00511.During the procedure, the sheath broke inside the femoral vein.A vascular surgeon was able to remove the sheath.A second sheath was used and the device kinked and formed in the device.
Additional Manufacturer Narrative
One fast-cath hemostasis introducer was returned to the manufacturer for analysis.The reported event of the reported event of a broken sheath was confirmed.The sheath had been torn at a bend proximal to the distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend and tear is consistent with damage during use.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 7 F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9086474
• Report Number: 3005334138-2019-00512
• Device Sequence Number: 16848965
• Product Code: DYB
• UDI-Device Identifier: 05414734216951
• UDI-Public: 05414734216951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K894343
• 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): 11/08/2019

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: 10/31/2021
• Device Model Number: 406702
• Device Catalogue Number: 406702
• Device Lot Number: 6746108
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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