MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Gas/Air Leak (2946)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/04/2021

Event Type  Injury  

Manufacturer Narrative

Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.

Event Description

Medwatch mw5100645 received from fda on 27apr2021 reported: it was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) alarm noted "no gas" and it was not inflating.All connections secure, no external evidence of leakage.Rn and charge rn at bedside.Md to bedside and requested another balloon for exchange of device.Upon removal of previously implanted balloon, noted to have large hole.Balloon placed in biohazard bag and saved as evidence of equipment failure.Patient remained generally hemodynamically stable.Although there was a significant drop in sbp while balloon out.Patient required emergent bedside surgery to repair femoral artery.Patient is a (b)(6) year old lady with no previous cardiac history.She present today for chest discomfort, dyspnea on exertion.She started noticing dyspnea exertion, chest discomfort when she was walking around 1 week ago.Denies resting symptoms, no orthopnea, no pnd, no presyncope or syncope.She went to see her pcp earlier today as scheduled.An ekg was done, which was concerning for acute coronary syndrome.She was sent to emergency room immediately.She is resting without distress when i saw her.No chest pain, no chest pressure, no orthopnea, no pnd.Her ekg showed st depression, but no indication of stemi.She has been hemodynamics stable.Troponin is mildly elevated.Fda safety report id # (b)(4) this report is for the cardiosave iabp.The iab catheter involved in this event is reported separately on mfg report number 2248146-2021-00251.

Manufacturer Narrative

Updated fields; b4, b6, g3, g6, g7, h2, h4, h6, h10, h11.Corrected fields; d1, d4, d10.A getinge field service engineer (fse) was not dispatched to evaluate the iabp unit because a follow-up call was placed several minutes later and the rn reports a new balloon was placed and the old one was discarded.The customer was in no position to obtain complaint information at the time and the call ended.If information is received, we will reopen and update the complaint.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11864504
• MDR Text Key: 264117248
• Report Number: 2249723-2021-01078
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB; IAB SENSATION PUS 8FR. 50CC
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 80 KG