MAUDE Adverse Event Report: ST. JUDE MEDICAL ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER; INTRODUCER, CATHETER

Model Number	C407698
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
After a portico procedure, the ultimum hemostasis introducer was removed but the hemostasis valve detached from the shaft, which caused a massive hemorrhage.While the shaft was still inside the left iliac artery, manual compression was applied to the groin to maintain femoral hemostasis, but the compression deformed the shaft of the introducer.The deformed shaft then caused an iliac lesion, which was treated with a four covered stent.The left iliac artery was still pervious multiple days after the procedure.
Additional Manufacturer Narrative
Product evaluation: the reported event of hemostasis hub detachment and sheath tubing damage was confirmed.Visual inspection revealed that the hemostasis hub had been detached and separated from the sheath tubing; the proximal end of the sheath tubing had been gouged, scratched and creased; the distal end of the sheath tubing had been flattened and folded and the distal tip had been split.Additional investigation revealed the header wash was formed properly and a portion of sheath tubing was still adhered to the hub.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the detached hemostasis hub remains unknown.The cause of the sheath tubing damage is consistent with damage during use.The ultimum introducer sheath instruction for use (ifu) states to follow normal accepted practice for vessel puncture, guidewire insertion, vessel dilator and hemostasis introducer use.Always advance dilator/sheath assembly over appropriate sized guidewire to the appropriate anatomical site.The ultimum introducer sheath instruction for use (ifu) states to not attempt advancement without guidewire, severe vascular damage and / or injury may occur.The ultimum introducer sheath instruction for use (ifu) states to advance dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.

• Brand Name: ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7690164
• Report Number: 3005334138-2018-00186
• Device Sequence Number: 16370337
• Product Code: DYB
• UDI-Device Identifier: 05415067009692
• UDI-Public: 05415067009692
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K092575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: C407698
• Device Catalogue Number: C407698
• Device Lot Number: 6238291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: 80 YR
• Patient Weight: 60