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

Catalog Number 0684-00-0474

Device Problem Positioning Problem (3009)

Patient Problems Death (1802); Great Vessel Perforation (2152)

Event Date 10/09/2016

Event Type  Death  

Manufacturer Narrative

The facility has indicated that the device is not available to return for evaluation, so we are unable to confirm the event.A review of the reported event has determined that the product was not used in accordance with the ifu which indicates that the iab catheter should be inserted through the femoral artery.A device and lot history record review and trend evaluation was completed for the reported product/event.No nonconformances were found that are considered to be related to the event.The customer indicated that the product is not returning to the manufacturer and we will be unable to complete an evaluation of the affected product.If additional information is supplied we will send a supplemental report with our additional findings.(b)(4).

Event Description

It was reported that there was a failure to introduce the iab catheter vessel dilator and femoral sheath with the guidewire through the thigh tissue of the patient.The doctor then inserted it through the ascending aorta and the balloon perforated the posterior wall of the aorta into the pleura.The patient required repair of the aortic arch perforation, which was performed during cabg.The patient was reported to have expired.

• Brand Name: LINEAR 7.5 FR. 34CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 6075537
• MDR Text Key: 59043208
• Report Number: 2248146-2016-00088
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 50 YR