MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

Device Problems Defective Component (2292); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Complete event site name - (b)(6) university.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 that during insertion of the intra-aortic balloon (iab), an obstruction was found along the guidewire.The doctor checked the balloon and found the lumen was broken.The balloon was replaced to continue therapy.

Manufacturer Narrative

The product was returned with the membrane completely folded with traces of blood on the exterior & interior of the catheter.The one-way valve was also returned and still attached to the extracorporeal tubing.Two (2) inner lumen kinks were observed at approximately 7.6 & 13.7cm from the iab tip.A break in the inner lumen was also observed which appeared to have been the result of a severe kink at approximately 77.2cm from the iab tip.Lastly, a catheter kink was observed closest to the y-fitting at approximately 77.2cm from the iab tip.The one-way valve was vacuum tested and it held vacuum.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and no leaks were detected.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed causing the reported difficulty to advance the iab through the guidewire.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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.Reference complaint #(b)(4).

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), an obstruction was found along the guidewire.The doctor checked the balloon and found the lumen was broken.The balloon was replaced to continue therapy.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8887221
• MDR Text Key: 154113159
• Report Number: 2248146-2019-00660
• 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
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000082761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 60