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

Catalog Number 0684-00-0293

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2019

Event Type  malfunction  

Manufacturer Narrative

(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 during insertion of the intra-aortic balloon(iab), the guide wire was unable to be inserted through the balloon lumen.There was no reported injury to the patient.

Event Description

It was reported during insertion of the intra-aortic balloon(iab), the guide wire was unable to be inserted through the balloon lumen.There was no reported injury to the patient.

Manufacturer Narrative

'brand name' changed from linear 7.5 fr.40cc to mega 7.5fr.40cc.Catalog #' changed from 0684-00-0475 to 0684-00-0293.The product was returned with the membrane completely unfolded and extracorporeal tubing attached.The original guidewire (0.025") was returned with the product.Traces of blood was observed on the y-fitting.No kinks were observed on the catheter.The technician attempted to insert the original returned guidewire (0.025") through the inner lumen of the returned iab and found that the inner lumen was occluded.The technician was unable to clear the occlusion and evidence of dried blood was observed at the tip of the guide wire.The condition of the iab as received indicated an inner lumen occlusion.The evaluation confirms the reported problem.It is difficult to determine when the occlusion occurred, however, if this occurs during the procedure, it can cause guidewire insertion difficulty.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).

Manufacturer Narrative

Updated sections: b4, d10, g4, g7, h2, h3, h6, h10.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 # (b)(4).

Event Description

It was reported during insertion of the intra-aortic balloon(iab), the guide wire was unable to be inserted through the balloon lumen.There was no reported injury to the patient.

• Brand Name: MEGA 7.5FR. 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: 9583252
• MDR Text Key: 188206809
• Report Number: 2248146-2020-00023
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2022
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000092767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 67