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

Catalog Number IAB-06840-U

Device Problems Leak/Splash (1354); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred during use while in the cathlab.The md inserted the iab-06840-u through the teflon sheath via right femoral artery and felt a little resistance during the insertion.Several minutes after pumping was started, light leak/helium loss 2 was displayed on the screen.The user checked the gas, but no problem was found.As a result, the iab was removed successfully.A new kit was opened and inserted through the same insertion site (right femoral artery) without issue and intra-aortic balloon pump (iabp) therapy continued as planned.Pump strips were generated.The iabp used during this event was an iabp-0500j, serial number (b)(4).There was no report of patient death, complications or injury.No medical/surgical intervention was required.It was stated there was no delay or interruption in therapy; however, there was the time to remove, prep and insert a new iab.The patient outcome is good.

Manufacturer Narrative

Complaint no.(b)(4).Sample will not be returned as it was discarded.

• 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 assoc. ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 3957896
• MDR Text Key: 4624911
• Report Number: 1219856-2014-00111
• 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: Other
• Type of Report: Initial
• Report Date: 05/29/2014

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: KF2053160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/17/2014
• 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
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 85