MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD UNKNOWN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number UNKNOWN

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.(b)(4).

Event Description

It was reported that prior to use of the intra-aortic balloon (iab), 55 catheters appeared to have moisture inside the packaging.There was no patient involvement.This report is for #50 of the 55 devices.

Manufacturer Narrative

Initially reported; it was reported that prior to use of the intra-aortic balloon (iab), 55 catheters appeared to have moisture inside the packaging.There was no patient involvement.This report is for #50 of the 55 devices.It was initially reported that there were 55 intra-aortic balloons (iab) catheters.This is being corrected to 41 catheters.Initial report of #50 of the 55 (this report) is being cancelled.Complaint # (b)(4), record id # (b)(4).

Event Description

It was initially reported that there were 55 intra-aortic balloons (iab) catheters.This is being corrected to 41 catheters.Initial report of #50 of the 55 (this report) is being cancelled.

• Brand Name: UNKNOWN
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8545199
• MDR Text Key: 143584585
• Report Number: 2248146-2019-00372
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1