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 Filling Problem (1233)

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

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

Complete initial reporter name: (b)(6).Occupation: administrator/ supervisor.Additional reporter name: (b)(6)., icu rn.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 during the fourth day of intra-aortic balloon (iab) therapy, the console generated a leak in iab circuit alarm approximately every five minutes.The customer had swapped out the console but the issue continued.Troubleshooting did not reveal a leak.There was no evidence of blood in the catheter and all connections of catheter/pump/safety disc were secured.There was no condensation in the tubing.The patient had a large chest and belly and was freely moving in the bed.Nothing obvious was precipitating the alarm.When using the ¿iab fill¿ key, an auto-fill failure occurred.The customer turned down the augmentation setting by two bars and put tension on the catheter.This allowed the balloon to fill, pump, and resolved the alarms.A chest x-ray was taken and it was later decided to replace the iab.There was no patient harm or adverse event reported.

Manufacturer Narrative

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)(4).

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint # (b)(4).

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Device evaluation: the product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.The extender tubing and one-way valve were also returned.The one-way valve was attached to the extracorporeal tubing.A catheter tubing kink/break was observed near the y-fitting at approximately 76cm from the iab tip.No other damage observed.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed and a leak was detected at the catheter tubing break site, measuring 0.051cm in length.The break found on the catheter tubing appeared to have been caused by a severe kink which eventually failed, causing the reported alarms.However, we are unable to determine when this break may have occurred.The evaluation confirmed the reported problem.A non-conforming material report review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period sep-19 through aug-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.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: 12391972
• MDR Text Key: 268940635
• Report Number: 2248146-2021-00558
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: 10607567106779
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/07/2021

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 Expiration Date: 02/03/2024
• Device Model Number: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000141744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 11/02/2021; 12/07/2021
• Supplement Dates FDA Received: 10/27/2021; 11/18/2021; 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300.; CS300
• Patient Age: 55 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 116 KG