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

Catalog Number IAB-S840C

Device Problems Bent (1059); Physical Resistance (2578); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

It was reported that prior to insertion the md vacuumed the balloon while in the tray properly.The sheath was inserted into the patient's left femoral artery.When the md inserted the intra-aortic balloon (iab) into the sheath he felt resistance.The md also noticed that the spring wire guide (swg) in the balloon was bent severly even though the md was inserting the iab very carefully.The md removed the iab and the sheath as one unit.The swg was removed and was bent.The md requested a second kit and prepped the second iab for insertion into the same insertion site (left femoral artery).There was no reported pt death, injury or complications.There was an under five minute delay in iabp therapy.Medical / surgical intervention was not required.Add'l info received stated that the central lumen of the iab bent during insertion through the sheath.As a result, the md could not advance the iab through the sheath.The iab, sheath and swg were removed as one unit.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 8 FR - 40 CC
• Type of Device: INTRA-AORTIC BALLON 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 associa ; 1400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3818361
• MDR Text Key: 19722111
• Report Number: 1219856-2014-00066
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2014

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-S840C
• Device Lot Number: KF2053178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2014
• Initial Date FDA Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• 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