MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 7.5 FR - 40 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-06840-U

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the event involved a male pt.Relevant medical history /diagnosis/medications: operation: coronary artery bypass graft (cabg) x 3 (left internal mammary artery-left anterior descending, saphenous vein graft-obtuse marginal, saphenous vein graft-right coronary artery).While in the intensive care unit the intra-aortic balloon (iab) was inserted via the pt's right femoral artery.It was reported that "the catheter's lumen for the arterial pressure detection was occluded and we were unable to flush the lumen despite our several attempts.The iab was removed and the md tried to flush the lumen again without success.As a result, another iab was inserted sheathless into the same insertion site.There was no reported pt death, injury or complications.Medical/surgical intervention was not required.There was no reported interruption or delay in intra-aortic balloon (iabp) therapy.The pt outcome is listed as favorable.It was noted that the pump used was the iap-0500, s/n (b)(4).

• Brand Name: IAB: 7.5 FR - 40 CC
• Type of Device: INTRA-AORTIC BALLOON PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, reg associate ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3807270
• MDR Text Key: 22210571
• Report Number: 1219856-2014-00062
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2014

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-06840-U
• Device Lot Number: KF3055905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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: 72 YR
• Patient Weight: 85