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

Catalog Number IAB-06840-U

Device Problems Physical Resistance (2578); Inadequate User Interface (2958)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the cath lab during insertion.During product prep it was observed the intra-aortic balloon (iab) was unwrapped when withdrawn from the case.The iab was previously performed negative pressure twice.Although the user manually wrapped the iab again and attempted to insert the iab, the iab could not be advanced into the teflon sheath via left femoral artery due to resistance.As a result, the iab was removed.Since the hospital did not have a spare 40cc iab in the hospital an arrow iab-(b)(4) was inserted via the same insertion site successfully; iabp therapy went on a planned.There was no report of patient death, complications or injury.No medical or surgical intervention is required.There was an approximate five minute delay or interruption in therapy with no harm to the patient noted.The patient outcome is good.

Manufacturer Narrative

(b)(4).Report is past 30 days due to teleflex (b)(6) sending late report to teleflex complaint management department.

• 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, reg. associate ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4611603
• MDR Text Key: 5763665
• Report Number: 1219856-2015-00058
• 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: 01/20/2015

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: KF3015084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2013
• 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