MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW FIBEROPTIX; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problems Occlusion Within Device (1423); Failure to Advance (2524); Physical Resistance (2578); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 07/29/2017

Event Type  malfunction  

Event Description

Responded to bedside from 75 feet away to intra-aortic balloon pump (iabp) alarm for kinked tubing.Tubing was inspected and not kinked so reset was tried.Upon reset, the drive line immediately started filling with blood.Balloon stopped and emergent attempt was made to exchange balloon over extra-long wire.As prepping for exchange, the pt's bp was lost despite escalating pressors.Once bp dropped the pacer lost capture and emergent doo mode initiated without capture.Cpr was started and cacl, and epi x 1 was given.After 1 minute of cpr pt regained bp and started pacing again.Iabp exchange continued during event.Wire passed until it met resistance but upon removing the balloon the site was lost.It was noted that the wire would not pass out of the tip of the balloon likely due to clot.At this point direct pressure was held and dr arrived at bedside and gained percutaneous arterial access through the right fem art.A 30 cc fiberoptic arrow balloon was placed.X-ray confirmed and repositioned with repeat x-ray with good position.Bp responded well and pressor requirements improved.

• Brand Name: ARROW FIBEROPTIX
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 6906658
• MDR Text Key: 87874474
• Report Number: 6906658
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR