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 Problem Component Missing (2306)

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

Event Date 06/27/2021

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 prior to insertion of the intra-aortic balloon (iab), it was noticed that the one-way valve was missing from the catheter tray.Therefore, the customer was unable to prep the iab.There was no patient harm or adverse event reported.

Event Description

N/a.

Manufacturer Narrative

Additional information: device available for eval changed to no.Added code: device discarded.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 jun-19 through may-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).H3 other text : device not returned.

• 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
• MDR Report Key: 12197222
• MDR Text Key: 262488501
• Report Number: 2248146-2021-00464
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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: 12/11/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000138155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 08/05/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN.