MAUDE Adverse Event Report: ABBOTT MEDICAL ULTIMUM SHEATH; INTRODUCER, CATHETER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Perforation of Vessels (2135); Retroperitoneal Hemorrhage (4483)

Event Date 04/23/2019

Event Type  Injury  

Event Description

It was reported that the patient developed a retroperitoneal bleed and coded after the 8fr.Introducer sheath and stsf catheter were inserted.Life saving measures were taken (cpr, intravenous medication, blood transfusion) and the patient recovered and stabilized.They were then sent to vascular surgery for vessel repair.The physician believes the issue was caused during sheath introduction, not bwi product related.The stsf catheter was introduced after the sheath placed, before knowledge of the patient injury.Bwi catheter in use: d134805, unknown lot number, catheter and packaging were disposed of.Additional information received stated that the physician's opinion regarding the cause of the adverse event was due to arterial puncture during sheath insertion.Iliac artery had a very acute bend which the sheath punctured when inserted.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ULTIMUM SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 17524800
• MDR Text Key: 321137806
• Report Number: MW5131743
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1