MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN INTRA-AORTIC BALLOON (IAB); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number UNKNOWN

Device Problem Difficult to Remove (1528)

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

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

Additional contact person - (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id #: (b)(4).H3 other text : device not returned.

Event Description

It was reported that the intra-aortic balloon (iab) was inserted at another facility on (b)(6) 2023 with recorded fluoroscopy.It was noted that the distal and proximal radiopaque markers were in correct position.On (b)(6) 2023, a percutaneous coronary intervention (pci) procedure was successfully done via radial artery access.During the procedure, it was noted and recorded that the distal and proximal radiopaque markers were nearly side by side at the proximal end (closer to the heart).The customer was able to finish the pci, and the physician attempted to remove the iab through she sheath but could not.After several attempts to remove the iab, the patient was then transferred to another facility.The iab was then surgically removed successfully.The patient was fine at this time, but required an unplanned day in the icu post-procedure.The physician stated that the iab had developed a ¿bulbous¿ shape at one end and that he is certain that the iab had not bent in half, or doubled over on itself while in the patient.There was no patient harm or adverse event reported.

Event Description

N/a.

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: UNKNOWN INTRA-AORTIC BALLOON (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: 17073215
• MDR Text Key: 316664413
• Report Number: 2248146-2023-00375
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Required Intervention