MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problems Inability to Auto-Fill (1044); Off-Label Use (1494)

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

Event Date 05/30/2021

Event Type  malfunction  

Manufacturer Narrative

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 intra-aortic balloon (iab) therapy, an auto-fill failure occurred multiple times after the physician repositioned the iab in the patient's left axillary.Axillary insertion is not the method described in the device instructions for use.The customer is aware of the off-label use.They have attempted several refills and swapped out the console.There was no blood in the helium tubing.The customer was advised to drop the augmentation to half and attempt another refill.This was successful.The decision was made to remove the iab due to length of time in standby at this point.The balloon was reported to have been in the patient for 29 days.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 product was returned cut in 2 pieces with blood on the exterior of the catheter and the maquet sheath covering the rear end of the membrane with the exposed portion completely unfolded.The cut was made at approximately 36cm from the iab tip.Two stopcocks were also returned.A catheter tubing/inner lumen kink was observed at approximately 0.4cm from the y-fitting.At this same location, the inner lumen and optical fiber were found broken from the severe kink.An underwater leak test of the balloon, catheter tubing, y-fitting and extracorporeal tubing was performed and a leak was detected at the inner lumen break site.The technician attempted to insert a 0.025¿ laboratory guidewire through the inner lumen and was found to be occluded with blood.Unable to clear the occlusion.The break found in the inner lumen appeared to have been the result of a severe kink flexing back and forth, which eventually failed allowing helium to escape and causing the reported alarm.The insertion was reported to be axillary which may have contributed to the reported failure.The evaluation confirmed the report 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 (b)(6) 2019 through (b)(6) 2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).

• Brand Name: SENSATION PLUS 8FR. 50CC 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: 12013418
• MDR Text Key: 256709399
• Report Number: 2248146-2021-00395
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000131135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 117 KG