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

Catalog Number 0684-00-0497

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2018

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the guidewire was inserted into the femoral artery, but the iab would not advance over the wire.The iab was removed and the perfusionist tried to flush the iab, but was unable to.A new iab was inserted successfully.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) insertion, the guidewire was inserted into the femoral artery, but the iab would not advance over the wire.The iab was removed and the perfusionist tried to flush the iab, but was unable to.A new iab was inserted successfully.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.One kink was found on the inner lumen and catheter tubing approximately 76.5cm from the iab tip.The technician attempted to flush/aspirate the inner lumen and was unable to do so.The technician then attempted to insert a 0.025¿ laboratory guide wire through the inner lumen of the returned iab and found that the inner lumen was kinked and occluded.The technician was able to clear the occlusion, however evidence of dried blood was observed at the tip of the guide wire.The condition of the iab as received indicated an occlusion and a kink in the inner lumen and catheter tubing.The evaluation confirmed the reported problems.The evaluation confirmed the reported problems.Blood clotting within the inner lumen will seal the passage.It is difficult to determine when the occlusion occurs, however, if this occurs during the procedure it will be impossible to flush or aspirate through the inner lumen.It can also cause poor or no pressure waveform and guide wire insertion difficulty.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7952064
• MDR Text Key: 123371404
• Report Number: 2248146-2018-00582
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K091449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000068141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Device Age: YR
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR