MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IPN000254

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 11/26/2023

Event Type  Injury  

Event Description

The patient was brought to the cath lab for intra-aortic balloon pump insertion (iabp), coronary arteriogram with possible intervention percutaneous coronary intervention (pci) lad, and right heart catheterization with possible pa line to stay.An intra-aortic balloon pump was inserted without difficulty.The patient was then admitted to the cardiac intensive care unit.Within 12 hours of placement of the iabp it was noted to have ruptured, as evidenced by the presence of blood in the helium line of the system.The patient was immediately taken to the operating room for attempted removal with vascular surgery.Right femoral artery cutdown and attempted removal of iabp with no success.Fluoroscopy demonstrated iabp was in the distal aorta and was not budging in the right iliac system.Angiogram demonstrated complete occlusion of the right iliac system by the iabp.Attempted snaring and sheathing of the iabp without success.Then an ex-lap with arteriotomy of the right cia was completed and there was successful removal of the iabp.

• Brand Name: ARROW
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 18290421
• MDR Text Key: 330039527
• Report Number: 18290421
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic