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

Model Number UNKNOWN

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

Patient Problems Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

The patient was coronary artery three vessel disease with calcification.So insert the iabp before pci.After operation removed the iab catheter smoothly.And use compression hemostasis.The next day found pseudoaneurysm formation at the puncture port.With dose- treatment, the pseudoaneurysm healed after 12 hours.According to local regulations, the customer report this case to nmpa.And the iab is not available for return.The associated intra-aortic balloon (iab) has been reported under medwatch report # 2248146-2021-00829.Patient height: 160 cm.

Manufacturer Narrative

The customer did not request service.The unit was returned to clinical use.A supplemental report will be submitted upon completion of our investigation.(b)(6).Not returned to manufacturer.

Event Description

N/a.

Manufacturer Narrative

Updated data: b4,g3,g6,h2,h10,h11.Corrected data: d10.

Manufacturer Narrative

Retraction mdr.Revert to blank.Based on information provided the iabp is not a getinge product.

Event Description

Based on information provided the iabp is not a getinge product.Please retract all info from your database.

• Brand Name: UNKNOWN
• 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: 13063335
• MDR Text Key: 284650777
• Report Number: 2249723-2021-02938
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARROW AUTOCAT 2; MEGA 40 CC3000162578
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 70 KG