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

Catalog Number IAB-06840-U

Device Problem Inflation Problem (1310)

Patient Problems Congestive Heart Failure (1783); Cardiogenic Shock (2262)

Event Date 02/02/2015

Event Type  malfunction  

Event Description

It was reported that the physician followed the instructions for use and inserted the iab-06840-u through the sheath via right femoral to the correct position, however the intra-aortic balloon (iab) could not fully open.The intra-aortic balloon pump (arrow kaat ii plus, s/n (b)(4)) alarmed "high pressure" and check for "kinked catheter," "partially wrapped balloon" and "balloon too large." as a result, the iab and sheath were removed together as one unit successfully.According to their judgment, the physician felt that the patient did not need the use of an iab and therefore did not insert another one for this case.There were no pump strips generated for review.The last x-ray was performed after placement and the findings were the iab could not fully open.The x-ray findings are available for review.There was no report of patient death, complications or injury.No medical/surgical intervention was required.There was less than a 30 minute delay or interruption in therapy with no harm to the patient noted.The patient outcome is the patient is currently in the intensive care unit.Additional information received on 02/13/2015 stated the user chose to use ecmo (extracorporeal membrane oxygenation) instead of iabp therapy.The patient outcome is fine now.

Manufacturer Narrative

Qn #(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 ; 2400 bernville rd.; reading, PA 19605 ; 6103780131
• MDR Report Key: 4546680
• MDR Text Key: 15905435
• Report Number: 1219856-2015-00033
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F14B0042
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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: 39 YR
• Patient Weight: 80