MAUDE Adverse Event Report: ARROW INTL., INC. IAB: 7.5 FR - 40 CC

Catalog Number IAB-06840-U

Device Problem Entrapment of Device (1212)

Patient Problems Angina (1710); Cardiopulmonary Arrest (1765); Renal Disease, End Stage (2039)

Event Date 02/09/2015

Event Type  Injury  

Event Description

It has been reported that while in the cardiac catheterization room the pt received intra aortic balloon pump (iabp) therapy following resuscitation from cpa (cardiopulmonary arrest) due to angina.Combined treatment: pci (percutaneous coronary intervention); vessel condition: no tortuous vessels, moderate calcification.The iab was inserted via a teflon sheath and into the pt's right femoral artery.Immediately after treatment started, a very small amount of blood was confirmed in the valve; however, the physician decided to continue an iabp treatment because the pt condition was bad.The pt received iabp therapy for six days and when the md found the pt's condition was stable the iab was to be removed.Sequence of event update received from teleflex (b)(4): (b)(6) 2015 9:00 pm, since alarms occurred, the delivery volume was reduced from 40 cc to 30 cc for continuous treatment.On (b)(6) 2015 1:00 pm, the pt condition became stable and the physician decided to remove the iab; however, the iab got stuck around the bifurcation of common iliac artery and was impossible to remove.On (b)(6) 2015 5:30 am, the power of iabp was off.On (b)(6) 2015 1:00 am, the iab was removed surgically.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB: 7.5 FR - 40 CC
• 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: 4562210
• MDR Text Key: 5548201
• Report Number: 1219856-2015-00043
• 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: Physician
• Type of Report: Initial
• Report Date: 02/16/2015

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 Expiration Date: 08/31/2016
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F14H0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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
• Treatment: HEPARIN; DOPAMINE; FENTANYL; MIDAZOLAM; NORADRENALINE; DOBUTAMINE
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR