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

Model Number	C407595
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 dissection could not be conclusively determined.
Event or Problem Description
At the end of the interventional cerebral aneurysm embolization procedure, the guidewire was pushed out to pull out the vascular sheath and during the process, the guidewire punctured a blood vessel.Blood extravasation and subcutaneous congestion were noted.Compression and a vascular suture device were used to stabilize the patient.The guidewire was noted to be too hard.

• Brand Name: ULTIMUM HEMOSTASIS TRANSRADIAL KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11169502
• Report Number: 3005334138-2020-00655
• Device Sequence Number: 11491986
• Product Code: DYB
• UDI-Device Identifier: 05414734025690
• UDI-Public: 05414734025690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031137
• 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
• Report Date (Section B): 01/14/2021

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: 06/30/2023
• Device Model Number: C407595
• Device Catalogue Number: C407595
• Device Lot Number: 7581918
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 01/14/2021
• 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: Required Intervention