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

Catalog Number 0684-00-0567

Device Problems Kinked (1339); Inadequacy of Device Shape and/or Size (1583); Device Displays Incorrect Message (2591); Malposition of Device (2616)

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

Event Date 03/13/2018

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 approximately 5 minutes after intra-aortic balloon (iab) insertion a "leak in iab circuit" alarm was generated.The customer switched out iab pumps, but intermittently (roughly every 5 minutes), a similar leak alarm was triggered.The customer confirmed that there was no visible blood in the gas line.Next the customer did an iab fill, waited roughly 5 minutes, and the alarm occurred again and the alarms continued.The customer indicated that at one point they changed the extender tubing.The service representative suggested to the customer to double check the size of the catheter and they confirmed on the y fitting that the catheter was a 40cc catheter.They then double checked the size of the extender tubing and it was for a 50cc catheter.The customer went to retrieve another extender tubing, but stated the extender tubing said ¿for a 34, 35 and 40 cc catheter.¿ the customer read this back several times however the service representative stated that they were unaware of a 35 cc catheter that we manufacturer.Nevertheless, the customer tried this tubing, pumped for not more than 3-4 minutes and the leak alarm was generated again.The customer then went and retrieved tubing that indicated it was for a 34 and 40 cc catheter.They changed out the extender tubing for this and after 3-4 minutes, the alarm came up again.There were no issues noted with insertion.The customer was using a competitor sheath, indicating that the sheath was only 6¿.The service representative asked the customer if the patient had any tortuous anatomical conditions.The customer stated that there were some slight tortuous anomalies, and that it appeared that the catheter was having some challenges staying in place when looking under fluoroscopy.The tip did not seem to be quite where it needed to be, and that it seemed that perhaps the iab might be just a little too big for this patient.The service representative discussed trying to reposition the catheter, especially if there were any visible kinks.The service representative advised at that time the customer would need to change the iab.The customer stated the patient went to the or (operating room) for surgery.A new iab was inserted and there were no issues with this iab.The patient went for bypass surgery and was stable.There were no reported injuries to the patient.

Manufacturer Narrative

Added additional patient information to section and indication for use to section.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender and pressure tubing were also returned.Two kinks were found on the catheter tubing approximately 60.5cm and 75.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, pressure and extender tubing was performed and one leak was found on the catheter tubing near the y-fitting approximately 56.4cm from the iab tip.The optical fiber was also found to be broken at this location.The penetration found in the catheter tubing appears to have been caused by a sharp object.Though we are unable to determine when the penetration may have occurred, it is likely that it caused the reported alarm.The evaluation confirmed the reported leak alarm.The penetration within the catheter appears to have been caused by a sharp object.It is difficult to determine when the penetration may have occurred, however, it could cause the reported event.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.We are unable to confirm the reported iab migration because we are unable to mimic the clinical setting.(b)(4).

Event Description

It was reported that approximately 5 minutes after intra-aortic balloon (iab) insertion a "leak in iab circuit" alarm was generated.The customer switched out iab pumps, but intermittently (roughly every 5 minutes), a similar leak alarm was triggered.The customer confirmed that there was no visible blood in the gas line.Next the customer did an iab fill, waited roughly 5 minutes, and the alarm occurred again and the alarms continued.The customer indicated that at one point they changed the extender tubing.The service representative suggested to the customer to double check the size of the catheter and they confirmed on the y fitting that the catheter was a 40cc catheter.They then double checked the size of the extender tubing and it was for a 50cc catheter.The customer went to retrieve another extender tubing, but stated the extender tubing said ¿for a 34, 35 and 40 cc catheter.¿ the customer read this back several times however the service representative stated that they were unaware of a 35 cc catheter that we manufacturer.Nevertheless, the customer tried this tubing, pumped for not more than 3-4 minutes and the leak alarm was generated again.The customer then went and retrieved tubing that indicated it was for a 34 and 40 cc catheter.They changed out the extender tubing for this and after 3-4 minutes, the alarm came up again.There were no issues noted with insertion.The customer was using a competitor sheath, indicating that the sheath was only 6¿.The service representative asked the customer if the patient had any tortuous anatomical conditions.The customer stated that there were some slight tortuous anomalies, and that it appeared that the catheter was having some challenges staying in place when looking under fluoroscopy.The tip did not seem to be quite where it needed to be, and that it seemed that perhaps the iab might be just a little too big for this patient.The service representative discussed trying to reposition the catheter, especially if there were any visible kinks.The service representative advised at that time the customer would need to change the iab.The customer stated the event occurred after coronary angiogram in preparation for surgery in the or (operating room) for surgery.The patient was hemodynamically stable prior to the alarm.A new iab was inserted and there were no issues with this iab.The patient went for bypass surgery and was stable.There were no reported injuries to the patient.

• 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
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 7402481
• MDR Text Key: 105154688
• Report Number: 2248146-2018-00241
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000057646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 63