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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0293
Device Problem Material Rupture (1546)
Patient Problems Calcium Deposits/Calcification (1758); Hemorrhage/Bleeding (1888); Patient Problem/Medical Problem (2688)
Event Date 10/03/2018
Event Type  Injury  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the iab ruptured and was removed.After which, the patient required surgery for a retroperitoneal bleed.The patient moved their leg causing more bleeding which required a second surgery to repair the external iliac artery.The patient had an arterial hemorrhage from external iliac artery, just above the inguinal ligament.The patient received 12 units of packed red blood cells, 1 unit of platelets, and 9 units of fresh frozen plasma.According to the vascular surgeon the insertion site was a little elevated and difficult to hold pressure on.The customer stated that there were complications during insertion due to patient aortic calcification, peripheral vascular disease, temporary dialysis catheter was below insertion site of iab.The hemorrhage occurred 16 hours after initiation of therapy and therapy was interrupted by the iab rupture.A new iab was not reinserted.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior and interior of the catheter.The returned sheath was covering the proximal side of the balloon by a membrane taper only.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed and one leak was detected on the membrane approximately 0.3cm from the rear seal measuring 0.064cm in length.The reported leak was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the iab ruptured and was removed.After which, the patient required surgery for a retroperitoneal bleed.The patient moved their leg causing more bleeding which required a second surgery to repair the external iliac artery.The patient had an arterial hemorrhage from external iliac artery, just above the inguinal ligament.The patient received 12 units of packed red blood cells, 1 unit of platelets, and 9 units of fresh frozen plasma.According to the vascular surgeon the insertion site was a little elevated and difficult to hold pressure on.The customer stated that there were complications during insertion due to patient aortic calcification, peripheral vascular disease, temporary dialysis catheter was below insertion site of iab.The hemorrhage occurred 16 hours after initiation of therapy and therapy was interrupted by the iab rupture.A new iab was not reinserted.
 
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Brand Name
MEGA 7.5FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8018453
MDR Text Key125435857
Report Number2248146-2018-00618
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K120868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/11/2018
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? Yes
Device Operator Health Professional
Device Expiration Date06/27/2021
Device Catalogue Number0684-00-0293
Device Lot Number3000076259
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2018
Device Age YR
Initial Date Manufacturer Received 10/05/2018
Initial Date FDA Received10/30/2018
Supplement Dates Manufacturer Received12/06/2018
Supplement Dates FDA Received12/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age62 YR
Patient Weight54
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