MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0474

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

(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 #38 of the 55 devices.

Event Description

It was reported that there were 12 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 #5 of the 12 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 #38 of the 55 devices; complaint # (b)(4), record id # (b)(4).Section b5: corrected to; it was reported that there were 12 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 #5 of the 12 devices.Complaint # (b)(4), record id # (b)(4).Device not returned.

• Brand Name: LINEAR 7.5 FR. 34CC 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: 8545117
• MDR Text Key: 143583395
• Report Number: 2248146-2019-00360
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 0684-00-0474
• Device Lot Number: 3000081732
• 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: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1