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

Model Number	406123
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The fast-cath hemostasis introducer was advanced through the right femoral vein.When the operator twisted the hemostasis valve on the introducer to move it into place, the valve sheared off the introducer just distally to the end of the valve, leaving the remainder of the introducer within the vein.In order to retrieve the remainder of the introducer, a small incision was made in the groin and a set of surgical forceps was utilized to gain traction of the introducer.The remainder was retrieved, and the procedure was continued using a new sheath.The patient information is not available due to hospital privacy policy.
Additional Manufacturer Narrative
Product evaluation: the reported event of a sheath fracture was confirmed.The results of the investigation concluded that the sheath tubing had been fractured and separated into two sections, near the sheath hub.The sheath tubing appeared to have multiple cracks at the location of the fracture.The sheath hub appeared yellowish and was discolored.The attached tubing distal end appearance had similar damage, consistent with a mating surface to the aforementioned detached tubing.No other visual anomalies were noted.Information from the field stated that the fast-cath introducer had been removed from its shelf box and exposed to light.According to the instructions for use (ifu), the storage instructions warn that the product should be stored in cool, dark, dry place.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the sheath tubing fracture and detachment is consistent with exposure to light and subsequent material degradation.

• 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: 7793606
• Report Number: 3005334138-2018-00259
• Device Sequence Number: 11085462
• Product Code: DYB
• UDI-Device Identifier: 05414734014038
• UDI-Public: 05414734014038
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 406123
• Device Catalogue Number: 406123
• Device Lot Number: 5310448
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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