MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0567

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 the intra-aortic balloon (iab) ruptured inside patient during cabg(coronary artery bypass graft) procedure in icu (intensive care unit).The iab was removed and replaced.There was no reported injury the patient.The date of the event is unknown.

Manufacturer Narrative

The iab was returned in two parts completely separated with the membrane completely unfolded and blood on the exterior and interior of the catheter.The returned sheath was over the membrane by a taper only and severely accordioned along its length.The catheter tubing was cut approximately 40.9cm from the y-fitting and is where the optical fiber was found to be separated.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was not able to be performed due to the returned condition of the catheter.An underwater leak test of the extender tubing was performed and no leaks were found.The evaluation confirms the reported problems.However we are unable to determine when this may have occurred due to the returned condition of the catheter.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.Complaint #: (b)(4); record id: (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) ruptured inside patient during cabg(coronary artery bypass graft) procedure in icu (intensive care unit).The iab was removed and replaced.There was no reported injury the patient.The date of the event is unknown.Facility medwatch (b)(4) received by the manufacturer on 2jan2019 states as follows: patient had an iabp placed prior to a cabg (coronary artery bypass graft) surgery.Following, the iabp became loud and blood was baking up into the tubing.The balloon had ruptured inside of patient.Surgeon removed catheter and placed a new one.The next day, iabp began alarming to "check catheter" when in 1:1.It ran without issue on 1:2.Iabp helium tubing was noted to have blood flecks in it.The balloon had ruptured again inside of patient.The provider attempted to remove the iabp through sheath and the catheter fractured.Sheath and remaining portion of catheter were than removed.Patients blood pressure decreased during manual compression requiring albumin, levophed and dobutamine.Hemoglobin dropped from 9.4 to 7.1 by the following morning.Patient required 1 unit of prbcs (packed red blood cells).This submission is for the 1st iab used.

Manufacturer Narrative

Section b.5.Added information from facility medwatch (b)(4).Section e.4.Changed from: no to: yes.Section h.6.Evaluation method codes added code 3331.Complaint #: (b)(4), record #: (b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) ruptured inside patient during cabg(coronary artery bypass graft) procedure in icu (intensive care unit).The iab was removed and replaced.There was no reported injury the patient.The date of the event is unknown.Facility medwatch (b)(4) received by the manufacturer on 2jan2019 states as follows: patient had an iabp placed prior to a cabg (coronary artery bypass graft) surgery.Following, the iabp became loud and blood was baking up into the tubing.The balloon had ruptured inside of patient.Surgeon removed catheter and placed a new one.The next day, iabp began alarming to "check catheter" when in 1:1.It ran without issue on 1:2.Iabp helium tubing was noted to have blood flecks in it.The balloon had ruptured again inside of patient.The provider attempted to remove the iabp through sheath and the catheter fractured.Sheath and remaining portion of catheter were than removed.Patients blood pressure decreased during manual compression requiring albumin, levophed and dobutamine.Hemoglobin dropped from 9.4 to 7.1 by the following morning.Patient required 1 unit of prbcs (packed red blood cells).This submission is for the 1st iab used.

• Brand Name: SENSATION PLUS 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 Key: 8187001
• MDR Text Key: 131324326
• Report Number: 2248146-2018-00749
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000067525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 109