MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 8 FR - 40 CC FOS; INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM

Catalog Number IAB-05840-LWS

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problem Mitral Insufficiency (1963)

Event Date 05/23/2014

Event Type  Injury  

Event Description

It was reported that while in the cardiothoracic surgery operating room the intra-aortic balloon (iab) was inserted sheathless cia the pt's right femoral artery.While in the cardiothoracic surgery intensive care unit the pt received constant intra-aortic balloon pump (iabp) therapy after mitral valve replacement and bypass surgery.The pt had to be reanimated.After reanimation blood residues were noted in the helium tube and the iabp (s/n (b)(4)) alarmed "helium leak." the md removed the iab and blood was noted in the balloon.During inspection of the pump serous fluids were found in the condensation trap.A new iab-05840-lws was inserted into the pt's left femoral artery and despite the blood noted in the pump, the md's decided to continue therapy with the same pump (s/n(b)(4)).Prior to the event the pt received iabp therapy for more than 10 hours.There was a delay / interruption in iabp therapy (timeframe is unk).There were reported pt complications and medical / surgical intervention was required and described as "cardiopulmonary resuscitation." add'l info received on (b)(6) 2014 stated that the pt vitality is unstable.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory associa ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3885934
• MDR Text Key: 4651899
• Report Number: 1219856-2014-00107
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR