MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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), the balloon could not be advanced through the sheath.There was no reported injury to the patient.

Event Description

It was reported that during insertion of the intra-aortic balloon (iab), the balloon could not be advanced through the sheath.There was no reported injury to the patient.

Manufacturer Narrative

'date received by mfg' on initial emdr should have been 01/20/2020, not 01/20/2019.The iab was returned with the membrane loosely folded with traces of blood on the exterior of the catheter.The one-way valve and maquet sheath.The one-way valve was also returned and attached, along with a 6¿ maquet sheath.The sheath was found to be ribbed at 14.7 cm from the sheath hub.Additionally, the catheter tubing was noticed to be flattened along its length.This deformation may occur if a vacuum is held with the one-way valve for an extended period of time, causing the catheter tubing to lose its round shape.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The technician successfully inserted the laboratory 0.018" guidewire through the inner lumen and no signs of blood were observed on the guidewire.The inner lumen leak test was performed and passed with no leaks.Due to the returned condition of the iab, the complaint could not be confirmed to mimic the reported event.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).

• Brand Name: SENSATION 7FR. 40CC 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: 9688188
• MDR Text Key: 187576532
• Report Number: 2248146-2020-00081
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2019
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000087225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1