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

Catalog Number 0684-00-0575

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2020

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.Complaint#: (b)(4).

Event Description

It was reported after insertion of the intra-aortic balloon(iab) using a competitor sheath, the console generated a catheter restriction alarm.Staff suggested to the doctor to pull the sheath back slightly.The doctor removed the balloon and inserted second different size balloon to continue therapy.There was no reported injury to the patient.

Manufacturer Narrative

Patient information updated sex, age at time of event, date of birth, & weight.Suspect medical device updated serial number.Device manufacturers only updated device evaluated by mfg?, evaluation method codes ,evaluation result codes, evaluation conclusion codes, additional mfg narrative/corr.Data.The product was returned with the membrane completely unfolded with blood on the exterior of the catheter.A competitor sheath, along with a maquet sheath and extender tubing were also returned.Neither the competitor sheath nor the maquet sheath were over the catheter.No physical damage observed.An underwater leak test of the balloon, catheter tubing, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cs300 pump for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded.Based on the evaluation results, the reported event cannot be confirmed.We are unable to duplicate the clinical settings.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).

Event Description

It was reported after insertion of the intra-aortic balloon(iab) using a competitor sheath, the console generated a catheter restriction alarm.Staff suggested to the doctor to pull the sheath back slightly.The doctor removed the balloon and inserted second different size balloon to continue therapy.There was no reported injury to the patient.

• Brand Name: SENSATION PLUS 8FR. 50CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9897473
• MDR Text Key: 185517792
• Report Number: 2248146-2020-00175
• 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
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000110617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 110