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

Catalog Number IAB-06840-U

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problems Calcium Deposits/Calcification (1758); Myocardial Infarction (1969); Thrombus (2101)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported that the event involved a male pt, no tortuous vessels, mild calcification.Combined treatment: thrombus aspiration, balloon dilation.The intra-aortic balloon (iab) was used for the emergency case of acute myocardial infarction.Thrombi was found by the angiographic exam.While in the cath lab and per the instructions for use, pulled-negative was performed before using.The device was not inflated before using.The device was flushed at the time of setup.After inserting the teflon sheath into the right femoral artery, the md inserted the iab into the sheath.However, the md could not advance the iab due to resistance encountered.Therefore, a new iab was inserted (same insertion site) and it was successfully placed.There was no reported pt death, injury or complications.Medical / surgical intervention was not required.There was no reportedly or interruption in intra-aortic balloon pump (iabp) therapy.The pt outcome is listed as pt is "under follow up.".

Manufacturer Narrative

(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, regulatory associa ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4281166
• MDR Text Key: 18037347
• Report Number: 1219856-2014-00210
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K000729
• 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: 10/30/2014

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 Expiration Date: 12/31/2015
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 13F13M0021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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
• Treatment: ASPIRIN; NITROGLYVERIN; HEPARIN
• Patient Age: 83 YR
• Patient Weight: 65