MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Complete reporter name: (b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated a check iab catheter alarm.It was discovered that the iab had been dislodged.It was noted that a physician had removed a venous pacing wire from the right groin and while he was removing it, he had somehow grabbed and partially removed the iab catheter from the right femoral.This is when the alarm sounded.They were unable to advance the iab again.The iab tip was not visible on chest film and they then decided to remove the iab catheter.They did not have difficulty removing the iab.The patient began to experience "right flank pain" after removal of the balloon catheter.The pain was newly onset at the time of the pacing wire removal and with attempt to reposition iab catheter.The pain resolved after removal of iab catheter and sheath.The patient was on eptifibatide and heparin infusions at the time of pacing wire removal, but off for brief period (less than 20 minutes) prior to iab removal.Heparin and eptifibatide infusions restarted 2 to 3 hours after iab removal.There was no indication of hematoma, hemorrhage, or retroperitoneal bleed from diagnostic testing nor clinical evaluation.No blood transfusions nor vascular interventions.The patient was discharged and sent home.

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering the rear portion of the balloon.A kink was found on the catheter tubing approximately 40.6cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The evaluation determined a kink in the catheter.It is difficult to determine when or how a kink in the catheter occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period (b)(6) to (b)(6)was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12435364
• MDR Text Key: 270202239
• Report Number: 2248146-2021-00582
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2024
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000140637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1
• Treatment: VENOUS PACING WIRE / PACEMAKER.; VENOUS PACING WIRE / PACEMAKER
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 80