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

Catalog Number 0684-00-0575

Device Problem Backflow (1064)

Patient Problem Injury (2348)

Event Date 01/21/2019

Event Type  Injury  

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 during intra-aortic balloon (iab) therapy that there was a blood back event.The customer inquired if a rupture could cause a stroke from an air embolism.The injury was not attributed to the device by the facility.

Manufacturer Narrative

Model# change from : unknown to: 3000084497.Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extracorporeal tubing was not returned.The sensor cable was returned cut in two parts.One kink was found on the catheter tubing and inner lumen approximately 28.4cm from the iab tip.The optical fiber was found to be broken at this location.The inner lumen was found to be occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was detected at the kinked location that penetrated the catheter tubing and inner lumen.The penetration found in the catheter tubing and inner lumen appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing causing the reported problems.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.Reference complaint #(b)(4); record id (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, after approximately 69 hours of support, that an iab catheter restriction alarm was generated by the console.The alarm was left to continue for several hours at which time blood was observed inside the catheter tubing.It was reported that the patient lost consciousness and required intubation, at which time the catheter was removed and it was not replaced.The insertion of the catheter was reported to be left axillary, which is not described in the device instruction¿s for use.It was reported by the facility that it is unknown if the patient injury was caused or contributed to by the device.

Manufacturer Narrative

Additional information outcomes attributed to adverse event: [from]: life-threatening [to]: life-threatening, required intervention.It was reported that during intra-aortic balloon (iab) therapy that there was a blood back event.The customer inquired if a rupture could cause a stroke from an air embolism.The injury was not attributed to the device by the facility.It was reported that during intra-aortic balloon (iab) therapy, after approximately 69 hours of support, that an iab catheter restriction alarm was generated by the console.The alarm was left to continue for several hours at which time blood was observed inside the catheter tubing.It was reported that the patient lost consciousness and required intubation, at which time the catheter was removed and it was not replaced.The insertion of the catheter was reported to be axillary, which is not described in the device instruction¿s for use.It was reported by the facility that it is unknown if the patient injury was caused or contributed to by the device.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, after approximately 69 hours of support, that an iab catheter restriction alarm was generated by the console.The alarm was left to continue for several hours at which time blood was observed inside the catheter tubing.It was reported that the patient lost consciousness and required intubation, at which time the catheter was removed and it was not replaced.The insertion of the catheter was reported to be axillary, which is not described in the device instruction¿s for use.It was reported by the facility that it is unknown if the patient injury was caused or contributed to by the device.

• 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 07004
• MDR Report Key: 8364895
• MDR Text Key: 136979532
• Report Number: 2248146-2019-00122
• Device Sequence Number: 1
• Product Code: DSP
• 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,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2021
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Device Age: YR
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/24/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 04/04/2019
• Supplement Dates FDA Received: 03/14/2019; 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 114