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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Patient Problems Liver Damage/Dysfunction (1954); Renal Failure (2041)
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided. Additional information has been requested and if provided, a supplemental report will be submitted with any additional findings.
 
Event Description
It was reported via case report article in arya atheroscler 2018; volume 14; issue 3: 142-4, titled "combined association of liver and renal injury by intra-aortic balloon pump malposition" that during intra-aortic balloon pump (iabp) therapy, an unusual visceral complication occurred due to the malpositioning of the intra-aortic balloon catheter (iabc) in the aorta. A (b)(6) year man with severe left ventricular dysfunction underwent coronary artery bypass grafting (cabg) with the preoperative use of an iabp. Postoperative course was complicated by renal and hepatic failure. The early occurrence of complications during 36 hours after operation exhibited a serious vascular complication. The combination of acute renal and hepatic failure led to the suspension to occlusive effect of iabc on ostium of the aforementioned organs. The iabp was removed, and urine output immediately restored. Thereafter, daily slop dawn serum levels of aminotrasnferases were started, and became normal at the 10th day of operation. Case report: a (b)(6) year-old man, with severe left main coronary artery disease (cad), and with short stature (b)(6), was referred to our center for coronary artery bypass grafting (cabg). The patient scheduled for off pump cabg (opcab). Due to unstable hemodynamic condition, an iabp catheter (datascope, procure, state, dual lumen, 9. 5fr, 34ml, datascope inc, (b)(4), united states) was inserted percutaneously through the right femoral artery, and was attached to the datascope system via a console. Immediately after device insertion, with a counter pulsation and 100% augmentation, and a ratio of 1:1, the systolic blood pressure increased up to 90mmhg and urine output increased. The patient underwent an opcab operation (off-pump coronary artery bypass grafting) using conventional grafts such as the left internal thoracic artery and saphenous vein grafts. Following the extubation, urine output decreased that managed by diuretic and fluid therapy. Although, laboratory examination showed abrupt increasing of the following test: blood urea nitrogen (bun: 70mg/dl, creatinine (cr) 1. 6mg/dl. Asparate transaminase (ast) 80iu and alanine aminotransferase (alt) 70iu and acetate dehydrogenase (ldh) 350iu. Ast, alt and ldh values elevated seriously to 1200,3500 and 5500 iu, respectively. The bun and creatinine also increased to 80 to 2. 1mg/dl, respectively. The mean elevation of total bilirubin was also noted (total bilirubin:2. 5mg,dl). The distension caused the failure of doppler to reveal the condition of portal and liver venous and arterial flow blood flow, but showed the reduction of renal arterial blood flow. However, in a thoracic x-ray catheter's tip was not detected, and an abdominal x-ray showed that the balloon pump catheter's tip was displaced distally; uncovering of catheter dressing in right thigh revealed loosing of fixation suture of catheter to the skin in its correct position. The improper mismatching of the iabp catheter size was the patient length may be another possible cause of the liver, renal and mesenteric arterial malperfusion in this specific case. After iabp removal, the patient urine output was abruptly increased on the following hours. Than, the liver function tests, including alt, ast, ldh, total bilirubin, and prothrombin time continued to reduce and recovered drastically at the 10th day of the catheter removal; liver function tests returned to normal value at time of hospital discharge, too. The date of submission of the article was 05oct2017 however the date of acceptance was 03mar2018. The model of the datascope console referenced in the article is unknown, and the date of event is unknown. A separate report has been submitted for the intra-aortic balloon involved under medwatch #2248146-2018-00547.
 
Manufacturer Narrative
We have received information from the customer informing that data collection on this event is practically impossible and that the type/model iabp is not available as this event occurred six (6) years ago. In addition, there was no alleged malfunction of the iabp. No further information is available. Updated fields.
 
Event Description
It was reported via case report article in (b)(4) atheroscler 2018; volume 14; issue 3: 142-4, titled "combined association of liver and renal injury by intra-aortic balloon pump malposition" that during intra-aortic balloon pump (iabp) therapy, an unusual visceral complication occurred due to the malpositioning of the intra-aortic balloon catheter (iabc) in the aorta. A (b)(6) year man with severe left ventricular dysfunction underwent coronary artery bypass grafting (cabg) with the preoperative use of an iabp. Postoperative course was complicated by renal and hepatic failure. The early occurrence of complications during 36 hours after operation exhibited a serious vascular complication. The combination of acute renal and hepatic failure led to the suspension to occlusive effect of iabc on ostium of the aforementioned organs. The iabp was removed, and urine output immediately restored. Thereafter, daily slop dawn serum levels of aminotrasnferases were started, and became normal at the 10th day of operation. Case report: a 55-year-old man, with severe left main coronary artery disease (cad), and with short stature (150cm height) and 76 kg height, was referred to our center for coronary artery bypass grafting (cabg). The patient scheduled for off pump cabg(opcab). Due to unstable hemodynamic condition, an iabp catheter (datascope, procure, state, dual lumen, 9. 5fr, 34ml, datascope incmontreal nj united states) was inserted percutaneously through the right femoral artery, and was attached to the datascope system via a console. Immediately after device insertion, with a counter pulsation and 100% augmentation, and a ratio of 1:1, the systolic blood pressure increased up to 90mmhg and urine output increased. The patient underwent an opcab operation (off-pump coronary artery bypass grafting) using conventional grafts such as the left internal thoracic artery and saphenous vein grafts. Following the extubation, urine output decreased that managed by diuretic and fluid therapy. Although, laboratory examination showed abrupt increasing of the following test: blood urea nitrogen (bun: 70mg/dl, creatinine (cr) 1. 6mg/dl. Asparate transaminase (ast) 80iu and alanine aminotransferase (alt) 70iu and acetate dehydrogenase (ldh) 350iu. Ast, alt and ldh values elevated seriously to 1200,3500 and 5500 iu, respectively. The bun and creatinine also increased to 80 to 2. 1mg/dl, respectively. The mean elevation of total bilirubin was also noted (total bilirubin:2. 5mg,dl). The distension caused the failure of doppler to reveal the condition of portal and liver venous and arterial flow blood flow, but showed the reduction of renal arterial blood flow. However, in a thoracic x-ray catheter's tip was not detected, and an abdominal x-ray showed that the balloon pump catheter's tip was displaced distally; uncovering of catheter dressing in right thigh revealed loosing of fixation suture of catheter to the skin in its correct position. The improper mismatching of the iabp catheter size was the patient length may be another possible cause of the liver, renal and mesenteric arterial malperfusion in this specific case. After iabp removal, the patient urine output was abruptly increased on the following hours. Than, the liver function tests, including alt, ast, ldh, total bilirubin, and prothrombin time continued to reduce and recovered drastically at the 10th day of the catheter removal; liver function tests returned to normal value at time of hospital discharge, too. The date of submission of the article was 05oct2017 however the date of acceptance was 03mar2018. The model of the datascope console referenced in the article is unknown, and the date of event is unknown. A separate report has been submitted for the intra-aortic balloon involved under medwatch #2248146-2018-00547.
 
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Brand NameUNKNOWN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7894128
MDR Text Key120970788
Report Number2249723-2018-01633
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/20/2018 Patient Sequence Number: 1
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