MAUDE Adverse Event Report: ARROW INTL., INC. IAB-05840-LWS; IAB-AORTIC BALLOON FOS SYSTEM

Catalog Number IAB-05840-LWS

Device Problem Material Rupture (1546)

Patient Problems Cardiac Arrest (1762); Cardiogenic Shock (2262); Loss Of Pulse (2562)

Event Date 03/20/2015

Event Type  Injury  

Event Description

It has been reported that the iab (intra-aortic balloon catheter) was inserted in the cath.Lab on (b)(6) 2015.On (b)(6) in the icu the iab was removed because of blood in the gas shuttle line.The pump did trigger a helium alarm.According to the perfusionist, they experienced some difficulty removing the iab from the femoral artery.An incision was made to remove the iab catheter.The patient needed vascular repair after loss of pedal pulse and has a thigh hematoma.Another catheter was not placed.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB-05840-LWS
• Type of Device: IAB-AORTIC BALLOON FOS SYSTEM
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 4696925
• MDR Text Key: 20365661
• Report Number: 1219856-2015-00075
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14M0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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): Required Intervention