MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0497

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

It was reported that during the intra-aortic balloon (iab) insertion process, the introducer dilator broke into two pieces when trying to remove it from the patient.The iab was not used after this occurred.There was no patient harm or adverse event reported.

Manufacturer Narrative

(b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id # (b)(4).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #(b)(4).

• Brand Name: MEGA 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 17548896
• MDR Text Key: 321186609
• Report Number: 2248146-2023-00507
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: 10607567108001
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K091449
• 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
• Type of Report: Initial,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0497
• Device Lot Number: 3000293911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Male