MAUDE Adverse Event Report: ARROW INTERVENTIONAL, INC (SUBSIDIARY OF ARROW INTL, INC) AUTOCAT 2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Device Problems Air Leak (1008); Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 06/16/2015

Event Type  malfunction  

Event Description

Called emergently to the bedside for acute episode of frothy blood in the iabp drive line.Pt hemodynamically stable and attending emergently paged.Decision was made to remove and not replace the iabp at this time.Using sterile technique the right femoral iabp was removed intact over a wire and a right femoral arterial sheath was replaced over the same wire in case a new iabp was needed.The iabp came out without drag or effort and was noted to have some blood within the balloon.The balloon was further inspected under water with a notable air leak approx 2 cm from the hub (away from the tip).The pt tolerated the procedure well.Attending was present and supervised the procedure.Distal pulses intact.Rupture is potential complication of device and likely due to calcium in the aorta.Rupture was recognized quickly by both nursing and app team.Iabp was quickly removed and no complications notable at this time.Reporting is mainly due to the incident itself.

• Brand Name: AUTOCAT 2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERVENTIONAL, INC (SUBSIDIARY OF ARROW INTL, INC); 9 plymouth street; everett MA 02149
• MDR Report Key: 4890945
• MDR Text Key: 18875359
• Report Number: 4890945
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR