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

Catalog Number 0684-00-0475

Device Problems Restricted Flow rate (1248); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 catheter restriction alarm.Soon after the alarm, blood was seen in the helium tubing.The catheter was then removed from the patient.The physician who performed the iab insertion claims to have encountered tortuosity while inserting the catheter.There was no reported injury to the patient.

Manufacturer Narrative

Updated sections: b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and blood was observed on the interior and exterior of the catheter.The extracorporeal, extender and pressure tubing were also returned.Two kinks were observed on the catheter tubing at 70.4 cm and 76.5 cm from the iab tip.In underwater leak test of the balloon, catheter, inner lumen, y-fitting, extracorporeal, extender and pressure tubing was performed and one leak was detected on the membrane approximately 1.28 cm from the rear seal measuring 0.19 cm in length.The technician then attempted to insert a laboratory 0.025¿ guide wire through the inner lumen of the returned iab and found slight traces of blood.The inner lumen was able to be cleared.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found in the membrane appears to have been caused by a sharp object.We are unable to determine when the penetration 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 that during intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm.Soon after the alarm, blood was seen in the helium tubing.The catheter was then removed from the patient.The physician who performed the iab insertion claims to have encountered tortuosity while inserting the catheter.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9717579
• MDR Text Key: 187570277
• Report Number: 2248146-2020-00098
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000105530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 77