MAUDE Adverse Event Report: DATASCOPE CORP. PERCOR STAT-DL 9.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Liver Damage/Dysfunction (1954); Renal Failure (2041); Urinary Retention (2119); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.A review of the provided information supports the indicated improper catheter choice for therapy of a 150 cm patient.The 34cc iab is suggested for use on patients that are 152 to 162 cm, making the catheter chosen by the healthcare provider oversized.(b)(4).

Event Description

It was reported via case report 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 a patient, while undergoing intra-aortic balloon (iab) therapy had a malpositioned iab.The abstract and case report states as follows: "we report an unusual visceral complication of intra-aortic balloon pump (iabp) due to the malpositioning of the catheter in the aorta.A (b)(6) man with severe left ventricular dysfunction underwent coronary artery bypass grafting (cabg) with the preoperative use of an intra-aortic balloon pump.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 intra-aortic balloon pump catheter on ostium of the aforementioned organs.The intra-aortic balloon pump was removed, and urine output immediately restored.Thereafter, daily slop dawn serum levels of aminotransferases were started, and became normal at the 10th day of operation.Case report: a (b)(6) man, with severe left main coronary artery disease (cad), and with short stature ((b)(6)) and (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 (percor stat-dl 9.5 fr.34 cc iab) 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 percor stat-dl 9.5 fr.34 cc iab is obsolete and no longer manufactured.The date of the event is unknown.

Manufacturer Narrative

Correction: section e.1 changed from: isfahan university to: imam ali hospital.Section g.7.Should have included "initial" in the previous submission.Section.H.1.Changed from: malfunction to: serious injury.Section b.5.Additional event information added.Complaint # (b)(4).

Event Description

It was reported via case report 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 a patient, while undergoing intra-aortic balloon (iab) therapy had a malpositioned iab.The abstract and case report states as follows: "we report an unusual visceral complication of intra-aortic balloon pump (iabp) due to the malpositioning of the catheter in the aorta.A 55 year man with severe left ventricular dysfunction underwent coronary artery bypass grafting (cabg) with the preoperative use of an intra-aortic balloon pump.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 intra-aortic balloon pump catheter on ostium of the aforementioned organs.The intra-aortic balloon pump 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 weight, 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 (percor stat-dl 9.5 fr.34 cc iab) 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 percor stat-dl 9.5 fr.34 cc iab is obsolete and no longer manufactured.The date of the event is unknown.The event occurred 36 hours after initiation of therapy.Therapy was interrupted due to hepatic and renal symptoms where iab malposition was suspected.The iab was inserted in the operating room and afterwards the patient was transported to the intensive care unit however therapy was not reinitiated.The customer states because of the hepatic and renal symptoms the therapy was discontinued.Although the event date is not available, it was reported that this event occurred 6 years ago.

• Brand Name: PERCOR STAT-DL 9.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 14 philips parkway; montvale NJ 07645
• MDR Report Key: 7881271
• MDR Text Key: 121449910
• Report Number: 2248146-2018-00547
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 76