MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problem Leak/Splash (1354)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported that after insertion, an intra-aortic balloon (iab) rupture was immediately noticed.The iab was replaced and therapy was provided.There was no patient harm or adverse event reported.

Manufacturer Narrative

Initial reporter full name: (b)(6).Event site postal code: (b)(6).The device was not returned and could not be evaluated.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Reference complaint # (b)(4).

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.Photos were provided and reviewed.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and a leak was observed at the iab tip and front seal of the membrane detached from the iab tip.The complaint was confirmed in determining that the cause of the leak came from the membrane detaching from the iab tip.The dhr was reviewed to determine that the device followed all standard procedures in the assembly of the product and was deemed acceptable before leaving the manufacturing facility.The current control for detaching membranes are leak testing checks, which were conducted twice by both production and qc inspection.Therefore, the root cause on when or why the membrane detached from the iab cannot be determined, as the current controls show that it cannot have happened during the manufacture of the device; the device is determined to have failed only after leaving the manufacturing facility.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).

Event Description

N/a.

• Brand Name: SENSATION 7FR. 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: 18790584
• MDR Text Key: 337072460
• Report Number: 2248146-2024-00117
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000316398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 101 KG