MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0469-01

Device Problems Inability to Auto-Fill (1044); Gas/Air Leak (2946)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  Injury  

Event Description

It was reported that after approximately three months of intra-aortic balloon (iab) therapy, the console generated auto-fill failure and gas loss alarms.The insertion was reported to be axillary, which is not the method described in the device instructions for use.It was noted that the patient's condition was deteriorating over the last day or two, prior to the alarms.Without iab therapy, the patient's condition continued to decline.The iab was later removed and replaced with a different manufacturer's device.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

Corrected fields: adverse event/product problem, outcome attributed to ae, describe event or problem, type of reportable event, health effect ¿ clinical code, health effect ¿ impact codes.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).

Event Description

It was reported that after approximately three months of intra-aortic balloon (iab) therapy, the console generated auto-fill failure and gas loss alarms.The insertion was reported to be axillary, which is not the method described in the device instructions for use.It was noted that the patient's condition was deteriorating over the last day or two, prior to the alarms.Without iab therapy, the patient's condition continued to decline.The iab was later removed and replaced with a different manufacturer's device.This report is for the iab.A separate report has been submitted for the cardiosave iabp under mfg report number 2249723-2021-02644.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior and in the catheter tubing, pressure tubing, and extracorporeal tubing.The catheter tubing was cut at approximately 51.82 cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, pressure tubing, extender tubing, and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1.27cm from the y-fitting and measured approximately 0.005 cm in length.The reported problems were most likely triggered by the leak found on the catheter tubing.We are unable to determine when this may have occurred.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 nov-2019 through oct-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

Event Description

N/a.

• Brand Name: SENSATION 7FR. 34CC 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: 12806257
• MDR Text Key: 280777352
• Report Number: 2248146-2021-00746
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: 10607567106755
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Model Number: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000134799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/16/2021; 12/16/2021
• Supplement Dates FDA Received: 11/18/2021; 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE PUMP CH300432D9 IMPELLA
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 102 KG