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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/16/2019

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. There was no reported malfunction of the iabp. Additionally, the customer did not provide the name, model or serial number of the iabp used during this event. Additional information has been requested from the customer with regard to the event and status of the iabp. A supplemental report will be submitted if this information is provided to us. The full name of the event site is (b)(6). Not returned to manufacturer.

Event Description

It was reported that the nurse from the icu called to ask questions about intra-aortic balloon (iab) length. At the time, the patient was in the operating room (or) for iab removal and the customer was having difficulty removing the balloon. When the patient was in the icu, blood was observed in the helium tubing and customer was unable to remove it in the unit. A vascular surgeon was called and the patient was sent to the operating room. The getinge representative spoke to the perfusionist in this case several times answering questions for the surgeon. Prior to speaking with them, the surgeon had cut the balloon at the shaft, just before where the balloon began, and what was left was then "stuck" in the iliac. The surgeon made a "cut down" incision, but was still unable to remove the iab. At one point, the getinge representative spoke to the surgeon in the operating room via speaker, as he had questions about removing the iab. The getinge representative suggested that there was a possibility of a large clot formation in the iab depending on how long it had been leaking. A second iab had already been placed, as the patient was unstable and had been on ecmo for a week and just taken off. It was later reported that the patient spent 10 hours in the or and the iab was removed. A large clot was reportedly found in the leaking iab. There was no reported malfunction of the iabp. The iab involved in this event has been reported under mfg report number 2248146-2019-00726.

• 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: 8994948
• MDR Text Key: 161957316
• Report Number: 2249723-2019-01451
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2019
• 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 Treatment Data

Date Received: 09/11/2019 Patient Sequence Number: 1