MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5 FR. 40CC IAB; INTRA-AORTIC BALLOON

Model Number 0684-00-0475

Device Problem Entrapment of Device (1212)

Patient Problem Death (1802)

Event Date 08/03/2012

Event Type  Death  

Event Description

Facility reported: we had yet another balloon pump catheter failure this afternoon in the ccu.At this time, we are unable to remove the catheter - the patient has an inr of >4 and is in severe cardiogenic shock on max dose vasopressors.However once her family arrives this evening, we will be withdrawing care.Once the patient has expired, i instructed our staff to remove the sheath and balloon catheter together.They will then send those, along with the flush system, to the cath lab.I have completed all the paperwork and the cath lab staff is aware they'll be receiving the catheter sometime this evening." facility reported on the reporting datasheet "iabp had sudden loss of waveform.Had been performing effectively.Transducer checked via ge pressure cable to confirm loss." death confirmation is based on the stated plan by the facility to remove the iab after the patient expired.As the product was received for evaluation this is implied evidence that a patient death has occurred.

Manufacturer Narrative

Product condition received: the product was with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter but it was not a datascope product and not reinforced.Pressure tubing and a saline bag was also returned.Three kinks were found on the catheter tubing approximately 37.8cm, 38.9cm and 39.9cm from the iab tip.It was difficult to ascertain when the kink occurred it may have occurred during or after iab removal, during iabp therapy or from patient movement.The sheath was found to be bent near the hub.This may have caused restriction in the catheter that resulted in difficulty reading the arterial waveform.Product evaluation: the technician attempted to insert a 0.025" laboratory guide wire through the inner lumen and resistance was only felt at the bend of the non-reinforced sheath.The sheath was repositioned and the restriction moved with the point of the bend in the sheath.Conclusion: the condition of the bent sheath on the iab as received may have caused the difficulty reading the arterial wave as reported.A review of the device history does not indicate any lot specific issues.(b)(4).

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: INTRA-AORTIC BALLOON
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer Contact: jason de sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3947333
• MDR Text Key: 4643853
• Report Number: 2248146-2014-00240
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2012

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2015
• Device Model Number: 0684-00-0475
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 2770
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2012
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2012
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Weight: 68