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

Model Number	407847
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event of a leak 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introducer sheath instructions for use (ifu) states damage to the valve assembly may occur if the inner catheter is withdrawn rapidly.The ultimum hemostasis introducer sheath instructions for use (ifu) instructs the user to insert the dilator into hemostasis valve and then follow normal accepted practice for vessel puncture, guidewire insertion, vessel dilator and hemostasis introducer use.The ultimum hemostasis introducer sheath ifu cautions the user to withdraw components slowly (withdraw the needle slowly from the dilator and withdraw the dilator slowly from the sheath) to minimize the vacuum created during withdrawal.All air should be aspirated slowly from the sheath using a syringe attached to one of the side ports of the three-way stopcock.Also the dilator, sheath, and catheter should be frequently flushed with saline to minimize the potential for air emboli.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.
Event or Problem Description
When the dilator was withdrawn from the sheath while inside the patient, arterial blood hemorrhaged out.There was no stop mechanism as expected on the device.As treatment, the sheath was removed and manual pressure was held.Patient's information (e.G.Age, weight, gender, ethnicity, race, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• 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: 7985296
• Report Number: 3005334138-2018-00366
• Device Sequence Number: 13879874
• Product Code: DYB
• UDI-Device Identifier: 05414734008969
• UDI-Public: 05414734008969
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K001346
• 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
• Report Date (Section B): 10/19/2018

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: 06/30/2021
• Device Model Number: 407847
• Device Catalogue Number: 407847
• Device Lot Number: 6542475
• 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: 10/14/2018
• Initial Report FDA Received Date: 10/19/2018
• 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: Other; Required Intervention