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

Model Number 0998-00-0800-53

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).A getinge service representative reported that this iabp unit was used with a yamato plus 30cc iab which was reported in mfg report number 2248146-2021-00389 (tw#473355).It was also reported that there was no anomalies or malfunction found on this cardiosave iabp unit.No blood was observed within the iabp unit, either.A supplemental report will be submitted when additional information is provided to us.

Event Description

It was reported that while removing the reported intra-aortic balloon (iab) catheter from the t-handle with maintaining vacuum by one-way valve, the physician encountered some resistance.Intra-aortic balloon(iab) therapy was started with this iab.After approximately three days of intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) console generated a check iab catheter alarm and went into standby mode.The helium tube was checked and blood was confirmed.The customer then attempted to remove the iab together with the sheath, but they felt resistance that the iab was caught by the blood vessel wall.A surgical incision was made and the iab was removed.It was noted that the patient did not have much calcification.The patient has been in stable condition.There was no reported malfunction on the iabp.A separate report has been submitted for the intra-aortic balloon(iab) under mfg report number 2248146-2021-00389.

Manufacturer Narrative

A getinge service representative reported that repair for the iabp associated with this complaint was not necessary.The iabp continued to work normally and has been continuously used for clinical use at the facility.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID TYP 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: 12041596
• MDR Text Key: 265003504
• Report Number: 2249723-2021-01320
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: YAMATO PLUS 30CC (SERIAL NUMBER: (B)(6).
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose