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

Model Number N/A

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 03/24/2018

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not reviewed per company standard operating procedure since the device serial number was not provided.Additional information has been requested.A supplemental report will be provided upon receipt.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured while in situ 2 days post-insertion.The intra-aortic balloon pump (iabp) was turned off immediately.The iab was then removed 25 minutes post-rupture.The health impact to the patient is reported to be premature cessation of mechanical support, which may cause unknown longer term complications related to renal/distal limb complications as the patient is still in acute phase.A complaint was opened to report the involved balloon catheter in this event under mfg report number 2248146-2018-00269.

Event Description

It was reported that the intra-aortic balloon (iab) ruptured while in situ 2 days post-insertion.The intra-aortic balloon pump (iabp) was turned off immediately.The iab was then removed 25 minutes post-rupture.The health impact to the patient is reported to be premature cessation of mechanical support, which may cause unknown longer term complications related to renal/distal limb complications as the patient is still in acute phase.A complaint was opened to report the involved balloon catheter in this event under mfg report number 2248146-2018-00269.

Manufacturer Narrative

Several attempts have been made to the customer to obtain additional information to update this complaint.However, despite our best efforts, no response has been provided.If additional information is provided at a later date, a supplemental report will be submitted accordingly.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7444065
• MDR Text Key: 105959556
• Report Number: 2249723-2018-00655
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• 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?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other