MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0568-01

Device Problem Optical Problem (3001)

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

Event Date 08/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be 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

The following was reported via medwatch (b)(4) received 28sep2021: patient required insertion of an iabp catheter.The catheter used was a maquet sensation plus 7.5 fiber optic balloon catheter.Upon insertion the iabp console was alarming fiber optic failure.The iabp catheter and console have 2 other trigger options, ecg and ap, both of which were working fine.We proceeded with the rest of the procedure using ecg and ap triggers.No adverse effect to patient or procedure.Catheter was successfully used on patient, unable to save catheter for return to manufacturer, patient was later transferred to (b)(6) campus.

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-2019 to aug-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 PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• MDR Report Key: 12657133
• MDR Text Key: 277974779
• Report Number: 2248146-2021-00678
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2021
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000083930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 53 YR