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

Catalog Number 0684-00-0475

Device Problems Difficult to Insert (1316); Obstruction of Flow (2423)

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

Event Date 02/07/2018

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.(b)(4).

Event Description

During initiation of iab (intra-aortic balloon) therapy, it was reported that during sheathless insertion, only half the length of the iab catheter crossed the femoral artery.The entry was found to be obstructed without a sheath.The iab catheter was replaced with no additional issues reported and therapy was able to be initiated.There was no reported injury to the patient.

Manufacturer Narrative

Correction: lot # changed from: 3000012006 to: 3000023366.Correction: expiration date changed from: 06/25/2018to 02/04/2019.Section: manufacture date changed from 06/25/2015 to: 02/04/2016.Device evaluation: the iab catheter was returned with the membrane completely unfolded.No blood was visible on the catheter.The sheath was not returned for evaluation.Four kinks were observed on the inner lumen within the membrane approximately 13cm, 16.3cm, 22.1cm, and 27.9cm from the iab tip.A laboratory insertion test was unable to be performed due to the kinked inner lumen and membrane being unfurled.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The condition of the iab as received indicated a kink on the inner lumen.A kink in the inner lumen can cause difficulty during insertion.The evaluation confirmed the reported problem.We are unable to conclusively determine when this may have occurred.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).

Event Description

During initiation of iab (intra-aortic balloon) therapy, it was reported that during sheathless insertion, only half the length of the iab catheter crossed the femoral artery.The entry was found to be obstructed without a sheath.The iab catheter was replaced with no additional issues reported and therapy was able to be initiated.There was no reported injury to the patient.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7313578
• MDR Text Key: 101718789
• Report Number: 2248146-2018-00143
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000012006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Device Age: YR
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65