MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Material Rupture (1546); Gas/Air Leak (2946); Material Split, Cut or Torn (4008)

Patient Problem Death (1802)

Event Date 01/23/2019

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.There was no alleged malfunction of the involved iabp.However, additional information has been requested, and a supplemental report will be submitted if pertinent information is provided.

Event Description

It was reported that intra-aortic balloon pump (iabp) therapy was being initiated pre-operatively for post-operative mechanical support and weaning from cpb (cardiopulmonary bypass) of a poor left ventricle patient.The iabp generated a "gas loss" alarm at the time of aortotomy for aortic cannulation and there was an appearance of ¿air¿ in the aortic cannula immediately post-cannulation.Blood was subsequently seen filling the extension line on the intra-aortic balloon catheter (iabc).There was an attempt to autofill, but this attempt failed and the iabc was removed and inspected and a longitudinal slit of approximately 5mm was seen approximately 5cm from tip of iab.A second iacb was inserted and used after the first balloon rupture and repositioned after the surgical procedure was completed and kept in to support the patient, but was withdrawn about 10 cm.The customer advised that the pressure trace on the iabp was good when asked if there were difficulties during pumping.Subsequently, the patient expired due to possible helium embolism to the brain.The customer did not allege a malfunction of the iabp and did not attribute the patient's death to the iabp.The iabp model was not made available to us.Separate reports were submitted on both iabcs under mfg nos.2248146-2019-00111 and 2248146-2019-00114.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 8363023
• MDR Text Key: 136908399
• Report Number: 2249723-2019-00292
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Weight: 64