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

Model Number 0684-00-0470-01

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Complete event site 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 the intra-aortic balloon (iab) was being removed in order to switch to extracorporeal membrane oxygenation (ecmo).After the console was turned off, it was observed that the iab was bent as it was being removed from the sheath.There was no patient harm or adverse event reported.

Manufacturer Narrative

Updated fields: b4, d10, g4, h3, h6, h10.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(6).

Event Description

N/a.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing and three-way stopcock were returned.Four kinks were observed on the inner lumen approximately 1.5cm , 2.0cm , 3.0cm and 3.8cm from the iab tip respectively.A kink was observed on the catheter tubing approximately 75.6 cm from the iab tip.The inner lumen was observed to be broken approximately 16.2cm from the iab tip.An optical fiber break was observed approximately 11.9cm from the iab tip.The inner lumen was observed to be broken approximately 16.2cm from the iab tip.An optical fiber break was observed approximately 11.9cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extender tubing was performed and no other leaks were detected.The reported event was confirmed by the evaluation.We are unable to determine when this occurred.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: 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: 14604932
• MDR Text Key: 294258485
• Report Number: 2248146-2022-00434
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000131123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 100 KG