MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	407845
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During insertion to the femoral artery, the ultimum hemostasis introducer became kinked.Due to the kink, the wire was lost in the artery.Before a new attempt, the artery had to be compressed and there was a 15 minute delay.After compression, a new puncture was made.In order to avoid another kink, 3 other introducers were used to dilate the artery.
Additional Manufacturer Narrative
Product evaluation: the reported event of the introducer kink and "the wire was lost in the artery" could not be confirmed.The results of the investigation are inconclusive since the device was not returned 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 ultimum hemostasis introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7887325
• Report Number: 3005334138-2018-00324
• Device Sequence Number: 1909063
• Product Code: DYB
• UDI-Device Identifier: 05414734011075
• UDI-Public: 05414734011075
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K001346
• 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): 10/15/2018

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 407845
• Device Catalogue Number: 407845
• Device Lot Number: 6401050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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