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

Catalog Number 0684-00-0475

Device Problems Device Contamination with Chemical or Other Material (2944); Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complete initial reporter name - (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 #15 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 #15 of the 55 devices; it was reported that there were 19 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #15 of the 19 devices.(b)(4).

Event Description

It was reported that there were 19 intra-aortic balloons (iab) catheters from this batch that appeared to have moisture inside the packaging.There was no patient involvement.This report is for #15 of the 19 devices.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8544857
• MDR Text Key: 142921237
• Report Number: 2248146-2019-00337
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K041281
• 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: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2022
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000087641
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1