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

Model Number N/A

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problems Death (1802); Thrombus (2101); Loss of consciousness (2418)

Event Date 09/11/2017

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per sop (b)(4) since the serial number for the unit was not provided.No additional information is available at this time.A supplemental report will be submitted if new information becomes available.

Event Description

Customer reported that while in use on a patient, the intra-aortic balloon (iab) ruptured resulting in helium emboli and decreased level of consciousness to the patient who later expired.The date of death is unknown.The customer also stated that when this incident occurred, the intra-aortic balloon pump (iabp) therapy was stopped and the patient was positioned head down.The customer does not attribute the patient's death to the iabp.Please refer to the balloon report under mfg report number 2248146-2017-00438.

• 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: 6918550
• MDR Text Key: 88371010
• Report Number: 2249723-2017-00593
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• 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: 09/14/2017
• 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: 55 YR
• Patient Weight: 73