MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 8 FR - 40 CC FOS

Catalog Number IAB-05840-LWS

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

It was reported via a call from the cardiac cath lab (ccl) rn to the clinical support specialist (css) on (b)(6) 2014 at 10:14 pm est that the pt was brought back down to the ccl this evening to replace the iab-05840-lws because the fiberoptix sensor (fos) was not working and the central lumen was clotted off.Pt with (b)(6) left main disease and is on a low dose of dopamine and levophed.There was no report of pt death, complications or injury.On (b)(6) 2014 at 8:15 am est the css called the intensive care unit and spoke with the male rn who is caring for this pt currently.The rn said the first iab was inserted on (b)(6) 2014 and the rn confirmed they used nss (normal saline solution) flush for the central lumen.The issue with the first iab started at 4 pm (pst) but this rn had no additional info about this first iab with the clotted central lumen and non functional fos as it occurred before the rn's shift.The pt outcome was okay.An update received on 3 (b)(6) 2014 from the css stated the last two iabs were inserted via the same insertion site.The rn said she "wasn't worried about the first one as it was after hours" and didn't provide any additional info on that one.The nurse caring for the pt couldn't provide any additional info on the first iab either.The first insertion site is unk.There is no additional info available.Refer to mdr 1219856-2014-00236 for the next event with the same pt.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB : 8 FR - 40 CC FOS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: kathryn myers, ra ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4355707
• MDR Text Key: 18064006
• Report Number: 1219856-2014-00237
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2014

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-05840-LWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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