MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0293

Device Problem Component Missing (2306)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter full name: (b)(6).Event site postal code: (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).

Event Description

It was reported that when opening the intra-aortic balloon (iab) packaging, the customer two insertion kits.The actual iab tray was missing from the packaging.There was no patient harm or adverse event reported.

Manufacturer Narrative

No decon or visual inspection performed since product was not returned and could not be evaluated.However, four photographs were provided by the facility with the iab kit they have received.We are unable to confirm the reported failure because parts were not sent back and for the evidence mentioned above.The iab kit might have been misplaced during the preparations of the surgery.Reference complaint #(b)(4).

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

A mega 7.5fr 40cc shelf carton was returned opened with two sealed and intact insertion kits.The iab kit was missing from the shelf carton.Photos were also provided and reviewed with the same observations.The reported event was confirmed by the evaluation.However, were unable to determine a root cause of how this occurred as our records do not indicate missing components for the batch.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint (b)(4).

• Brand Name: MEGA 7.5FR. 40CC 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: 17038109
• MDR Text Key: 316314387
• Report Number: 2248146-2023-00363
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567111339
• UDI-Public: 10607567111339
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K120868
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000288265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG