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

Catalog Number IAB-05840-LWS

Device Problem Aspiration Issue (2883)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/31/2013

Event Type  malfunction  

Event Description

It was reported that a phone call was received from the inventory control clerk regarding an intra-aortic balloon (iab) that was inserted into the pt.When they attempted to aspirate the central lumen they were only able to aspirated air and not blood.There is no pt info available at this time.An update received on (b)(4) 2014 stated that the iab was inserted for cardiogenic shock by the md in the cath lab via the left groin.The iab was removed after they could not aspirate the central lumen.Another catheter was not inserted.There was no death, injuries or complications.No medical or surgical interventions were required.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC FOS
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS)
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3777764
• MDR Text Key: 4443902
• Report Number: 1219856-2014-00013
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2014

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: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 01/14/2014
• 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
• Treatment: INTRA-AORTIC BALLOON PUMP