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

Catalog Number 0684-00-0475

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Event site postal code: (b)(6).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 that after the insertion of an intra-aortic balloon (iab), the physician found the central lumen to be blocked.After removing the balloon, the physician flushed the lumen to check the patency, and this led to catheter unblocked.There was no reported injury to the patient.

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.Reference complaint #(b)(4).

Event Description

It was reported that after the insertion of an intra-aortic balloon (iab), the physician found the central lumen to be blocked.After removing the balloon, the physician flushed the lumen to check the patency, and this led to catheter unblocked.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane loosely folded and blood found on the exterior of the catheter.The pressure tubing was also returned unused.A visual examination of the product did not detect any damage.The technician was able to successfully aspirate/flush the inner lumen.The technician attempted to insert a laboratory 0.025¿ guide wire through the inner lumen and was able to successfully insert the guide wire.No obstructions were felt.The reported event cannot be confirmed by the evaluation.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 that after the insertion of an intra-aortic balloon (iab), the physician found the central lumen to be blocked.After removing the balloon, the physician flushed the lumen to check the patency, and this led to catheter unblocked.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: 9873504
• MDR Text Key: 185518138
• Report Number: 2248146-2020-00173
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2020
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000055401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 72