MAUDE Adverse Event Report: ARROW INTL., INC. IAB 8 FR - 40 CC FOS; IAB-INTRA AORTIC BALLOON FOS SYSTEM

Catalog Number IAB-05840LWS

Device Problems Entrapment of Device (1212); Material Rupture (1546)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 03/31/2015

Event Type  Injury  

Event Description

It was reported via a hotline call from the rn in the cath lab regarding a pt that just came to the cath lab from the icu (intensive care unit).Iab was inserted yesterday ((b)(6) 2015) without incident in the cath lab, and then the pt was sent to icu.Today ((b)(6) 2015) the icu nurse reported to the cath lab that they had high pressure alarms through the night which then changed to helium loss.According to the rn this morning they observed blood in the gas tubing, and called the physician.The md was in a case and finished his case before going to the icu to check on the pt.The pump had been off for that entire time as recommended when blood is resent.The md attempted to remove the iab while in the icu first, but was only able to remove it part of the way, so they went to the cath lab from there.There were two md's present to attempt to remove the iab while in the cath lab, and this is the time that the rn called the hotline.The rn asked the clinical support specialist if this has happened before.The css explained to the rn that this does happen very rarely.The css discussed iab ruptures, and what can cause this to happen.The rn said that this pt does have a lot of calcification to the aorta which could explain the high pressure alarms and subsequent helium loss due to rupture.The css explained all this to her.The css then asked how long it took from the time the iab ruptured until the md attempted to initially remove the iab.The rn was not clear on the initial attempt at bedside, but it had been about 90 minutes by the time they got the pt to the cath lab.The pt was on a heparin drip, and this was held at the time of the initial call to the md about to report the iab rupture.The css then discussed that it is recommended that they consult vascular surgery to remove the iab surgically.The rn stated that she is going to pass this on the physician.The css told the rn that he would call back to check on progress.At 0930 am - the css rec'd a call from the operating room, where they are not surgically removing the iab.The vascular surgeon want to know how long the balloon itself is.The css explained to the vascular surgeon the length of a 40cc iab.The css also tried to get the sn for the iab, but they are not bale to get it at this time.The css asked them to save the iab once it was removed for return.An rn in the operating room, said that they will hold the balloon once it is out.At 1525 pm - the css called again and spoke with the rn in the cath lab.They have just finished with repairing the femoral artery from the removal of the iab.The css got the sn from the balloon, and indicated for iabp therapy: ami.The pt outcome is listed as stable pt.

Manufacturer Narrative

(b)(4).

• Brand Name: IAB 8 FR - 40 CC FOS
• Type of Device: IAB-INTRA AORTIC BALLOON FOS SYSTEM
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 9 plymouth st.; everett MA 02149
• Manufacturer Contact: anna rosenberger, clinical spe ; 2400 bernville rd; reading, PA 19605 ; 6104783117
• MDR Report Key: 4732445
• MDR Text Key: 5741594
• Report Number: 1219856-2015-00084
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2015

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 Catalogue Number: IAB-05840LWS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention