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

Catalog Number IAB-S840C

Device Problem Fluid/Blood Leak (1250)

Patient Problem Congestive Heart Failure (1783)

Event Date 01/26/2015

Event Type  malfunction  

Event Description

It was reported that the event involved a male patient while in the cardiac care unit during use.The physician inserted the intra-aortic balloon (iab) through the sheath via left femoral artery without issue.After insertion, blood flooded into the iab breakage prior to activating the autocat2wave; therefore the iab did not unwrap.As a result, the physician claimed the iab was removed from the patient successfully without the sheath.Therapy was delayed approximately 30 minutes while a new kit was opened and a second iab ((b)(4)) was inserted via the same insertion site without issue.There was no report of patient death or complications.No medical or surgical intervention was required.The patient outcome is fine.

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 street; everett MA 02149
• Manufacturer Contact: kathryn myers, regulatory assoc ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4494185
• MDR Text Key: 5332316
• Report Number: 1219856-2015-00024
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F14E0032
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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: 69 YR
• Patient Weight: 70