MAUDE Adverse Event Report: ARROW INTL., INC. IAB : 7 FR - 30 CC; INTRA-AORTIC BALLOON PRODUCTS

Catalog Number IAB-S730C

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problem Myocardial Infarction (1969)

Event Date 08/20/2014

Event Type  Injury  

Event Description

It was reported that the event occurred while in the cath lab during insertion.The md stated having followed the procedure of the ifu.The md could not advance the iab-s730c through the sheath via femoral artery due to severe resistance.As a result, the md removed the iab and sheath together as one unit and replaced it with a new kit via a different femoral artery site.Intra-aortic balloon pump (iabp) therapy went on successfully as planned with the second kit.The md stated there was no report of patient death, complications or injury.No medical/surgical intervention was required.There was an approximate 10 minute delay or interruption in therapy.The patient outcome is unknown.Additional information received on (b)(4) 2014 stated that the patient did not have a tortuous vessel.There was an approximate 10 minute delay or interruption in therapy with no harm to the patient.The patient outcome is the patient is recovering.The resistance at insertion seemed that something was interrupting when the iab was inserted into the sheath.The sheath type was unknown; the sheath was returned with the iab.It has been verified that the second iab was inserted via the patient's other femoral artery.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB : 7 FR - 30 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, associate ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4101739
• MDR Text Key: 4698789
• Report Number: 1219856-2014-00170
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K981660
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: IAB-S730C
• Device Lot Number: KF2083904
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2012
• 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 Outcome(s): Other