MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IAB: 8 FR - 40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-04840-U

Device Problem Fluid/Blood Leak (1250)

Patient Problems Congestive Heart Failure (1783); Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 10/12/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014 the pt arrived at the hospital with chf (congestive heart failure) anterior mi (myocardial infarction) identified, during the left heart catheterization for support of cardiogenic shock.The pt had cabg (coronary artery bypass grafting) x 2 with svg (saphenous vein graft) on (b)(6) 2014 at approximately 20:00hr and 23:30hr in the evening.The intra-aortic balloon (iab) was inserted sheathless via the pt's left femoral artery.While in the cardiac care unit the pt received intra-aortic balloon pump (iabp) therapy for two days when the pump alarmed gas alarm (class 1 alarm).There was blood in the line, the pump was turned off and the iab was removed stat.It was noted that prior to the event the pt was not moving and vitals were somewhat stable at the time, he was just lying in bed with the iabp therapy functioning.There was no another attempt to insert another iab.The iabp therapy was interrupted "indefinitely." there were reported pt complications, described as "the pt died after receiving two days of iabp therapy." medical / surgical intervention was required and described as "the iab was removed." pump strips were generated and are not available for review.X-rays were not performed.The interventional cardiologist does not believe that the device contributed or caused the pt's death.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4339592
• MDR Text Key: 5219064
• Report Number: 1219856-2014-00228
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K993966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-04840-U
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2013
• 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 Age: 82 YR
• Patient Weight: 110