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

Catalog Number 0684-00-0567

Device Problems Device Damaged Prior to Use (2284); Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2019

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), 3 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #1 of the 3 devices.

Event Description

It was reported that prior to use of the intra-aortic balloon (iab), 3 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #1 of the 3 devices.

Manufacturer Narrative

No decon or visual inspection of product performed since product was not returned.A review of the provided photographs confirms the damage to the shipping and user cartons inside of it.The product was not returned and so could not be evaluated.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The event is confirmed based on a review of the provided photographs.The most likely cause is damage that occurred during shipping or handling of the outer shipping carton.Complaint record id # (b)(4).

Manufacturer Narrative

A visual inspection of the returned product and provided photos determined that the packaging had suffered both physical and water damage.The evaluation confirms the reported problem.We are unable to conclusively determine when this may have occurred, but it is likely to have occurred during shipping or storage.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Record id: (b)(4), auto number: (b)(4), s/n: (b)(6).

Event Description

It was reported that prior to use of the intra-aortic balloon (iab), 3 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #1 of the 3 devices.

Manufacturer Narrative

Added device return date.Record id: (b)(4), auto number: (b)(4).

Event Description

It was reported that prior to use of the intra-aortic balloon (iab), 3 devices from this batch, the user cartons were wet.There was no patient involvement.This report is for #1 of the 3 devices.

• 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 07004
• MDR Report Key: 8561068
• MDR Text Key: 143588159
• Report Number: 2248146-2019-00386
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/12/2022
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000089933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Device Age: YR
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1