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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Dissection (2491)

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per getinge standard operating procedure since the serial number for the unit was not provided.We will submit a supplemental report if additional information is provided.Not returned to manufacturer.

Event Description

It was reported via a medical article that, a (b)(6)-year-old male was admitted in the setting of protracted chest pain, st segment abnormalities, and elevated troponin.Angiography revealed severe triple vessel disease, left main coronary artery stenosis, and severe left ventricular systolic dysfunction on ventriculography.Continued chest discomfort and hemodynamic instability prompted insertion of an intraaortic balloon pump (iabp) via the right femoral artery with fluoroscopy.Coronary artery bypass grafting was planned for the following day after transthoracic echocardiography.Examination of the descending aorta with intraoperative trans-esophageal echocardiography (tee) identified an intimal dissection flap with the intra-aortic balloon pump(iabp) positioned within the false lumen.Diastolic augmentation was being achieved through compression of the true lumen.The tip of the intra-aortic balloon pump(iabp) disrupted a region of grade v atheroma in the proximal descending aorta.An associated intimal tear demonstrated flow from the true to the false lumen during systole.We were unable to see how far the dissection extended proximally or distally; however, the lesion was identified in the distal aortic arch and descending aorta.The dissection was not seen in the ascending aorta, implying it ended somewhere in the aortic arch.Weaning of intra-aortic balloon pump(iabp) counterpulsation while augmenting inotropic support resulted in deteriorating hemodynamics.A guidewire was inserted into the left femoral artery, and after confirming position within the true lumen on tee, a second iabp was inserted.Augmentation within the true lumen commenced after the first intra-aortic balloon pump(iabp) device was removed.The possibility that the new iabp crossed the intimal flap along its course could not be excluded, and the proximal and distal extremes of the dissection were unknown.The procedure was postponed, and computed tomography (ct) aortography was performed.A type b aortic dissection was demonstrated extending from the distal aortic arch to the iabp insertion site in the right common femoral artery.The iabp did not cross the dissection flap at any point.Uneventful coronary artery bypass surgery was performed 72 hours later, and the patient was discharged home for ongoing follow-up and conservative management of the aortic pathology.

• Brand Name: UNKNOWN IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 9522076
• MDR Text Key: 184534174
• Report Number: 2249723-2019-02098
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR