MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR 50CC; INTRA-AORTIC BALLOON CATHETER

Model Number 0684-00-0575

Device Problems Entrapment of Device (1212); Difficult to Insert (1316)

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

Event Date 01/16/2014

Event Type  Death  

Event Description

This incident occurred during the second attempt at an intra-aortic balloon (iab) catheter insertion.The iab was prepped properly using the one-way valve, guidewire and 8fr sheath provided with the kit.It is believed that iab was not left in the t-handle until just prior to insertion as required in the instruction for use.The technician noticed that when the t-handle was removed, the membrane of the iab looked as if it was unfurled more than usual.The physician attempted insertion, however, when the membrane was half way inserted, it became stuck and could not be inserted further.The physician attempted to push the catheter further but it would not go.At this point, the physician decided to remove the iab and attempt a 3rd insertion using a larger non-maquet sheath.The third attempt was successful.It was reported that the pt was high risk and crashing prior to therapy.The pt made it through surgery until the next day and then expired on (b)(6) 2014.

Manufacturer Narrative

The intra-aortic balloon catheter was returned for eval on (b)(4) 2014, however, the sheath used during insertion was not returned.The device was sent for decontamination prior to testing.A vacuum was applied to the iab using the returned one-way valve.The valve performed according to specifications by successfully holding the vacuum.An insertion test was then performed, using an 8fr laboratory sheath similar to the one used by the facility during the reported facility during the reported failure.The iab was successfully inserted through the sheath w/o difficulty.In order to determine if a leak could have caused the reported "unraveling" experienced, a 4psi underwater leak test was performed on the iab, catheter, y-fitting and extracorporeal tubing and no leaks were detected.Additionally, device history records were reviewed and no non-conformities were found which could have caused the reported problem.Based on the results of the investigation, we are unable to confirm the reported failure.The device and returned components performed according to specifications.

• Brand Name: SENSATION PLUS 8FR 50CC
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ 07004
• Manufacturer Contact: jason de sousa ; 15 law drive; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 3669458
• MDR Text Key: 20657352
• Report Number: 2248146-2014-00012
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2014

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 Expiration Date: 04/17/2016
• Device Model Number: 0684-00-0575
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 2915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2014
• Initial Date FDA Received: 02/12/2014
• Date Device Manufactured: 04/01/2013
• 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: 61 YR
• Patient Weight: 88