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 Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

It was reported during intra-aortic balloon (iab) therapy an auto fill failure alarm occurred.The iabp was changed and the alarm recurred.The iab was removed.There was no reported injury to the patient.

Event Description

It was reported during intra-aortic balloon (iab) therapy an auto fill failure alarm occurred.The iabp was changed and the alarm recurred.The iab was removed.There was no reported injury to the patient.

Manufacturer Narrative

This 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 # (b)(4).

Manufacturer Narrative

Updated sections: date of report, device identification, date received by mfr, type of report, follow up type, device evaluated by mfr, device manufacture date, evaluation codes, additional narrative.The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.The extender tubing was also returned.One catheter tubing/optical fiber break was observed at approximately 76.5cm from the iab tip.Additionally, one inner lumen kink was observed also located at 76.5cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and one leak was detected at the catheter tubing break site, measuring 0.051cm in length.The break found on the catheter tubing appears to have been caused by a severe kink which eventually failed, causing an alarm.The evaluation confirms the reported problem.However, we are unable to determine when this may have occurred.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 record # (b)(4).

Event Description

It was reported during intra-aortic balloon (iab) therapy an auto fill failure alarm occurred.The iabp was changed and the alarm recurred.The iab was removed.There was no reported injury to the patient.

• 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: 9271520
• MDR Text Key: 198551463
• Report Number: 2248146-2019-00859
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000101068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 12/12/2019
• Supplement Dates FDA Received: 11/26/2019; 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 59