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

Model Number N/A

Device Problems Device Contamination with Body Fluid (2317); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.Several attempts were made to obtain additional information from the initial reporter regarding the event and status of the iabp.However, the initial reporter has advised that no additional information will be provided.A supplemental report will be submitted if additional information is made available.Device evaluated by mfr: not returned to manufacturer.

Event Description

The following was reported via medwatch uf/importer# (b)(4).¿intraortic artery balloon pump (iabp) placed; approximately 6 hours later the balloon pump start alarming flow restriction and the patient stated she could feel balloon pump inflating more in her axillary area; monitor tech was at bedside to assess lines for kinks/clots; balloon pump was restarted and noted to have blood returning in the nitrogen line and patient could feel a inflating sensation up in their neck to ears.Patient was taken to procedure room where the balloon pump was removed and found to have ruptured.¿ the iab involved in this complaint was reported under mfg report# 2248146-2019-00642.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8855290
• MDR Text Key: 153115831
• Report Number: 2249723-2019-01208
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 07/10/2019
• 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
• Treatment: LINEAR 7.5 FR. 34CC IAB WITH ACCESSORIES
• Patient Outcome(s): Required Intervention