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 Break (1069); Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944); Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

It was reported that prior to use of the intra-aortic balloon (iab), the user carton was damaged and moisture was observed inside of the product tray.There was no patient involvement.

Manufacturer Narrative

A visual examination of the photographs provided by the customer shows the shelf carton is damaged and there is moisture is present in the packaging, the device was returned unused and all parts included in the carton.The carton box was found to have slight crush damage on the corner.The evaluation consisted of a visual inspection confirming the presence of fluid inside the device packaging and damaged packaging.Pull membrane from retainer test was performed and no failures were noted.A sample of the fluid has been tested via infrared spectrum analysis.The attached infra-red spectrophotometer results confirmed that the substance was silicone on both the iab and insertion kit which had migrated inside the packaging of the device during storage.Silicone is used as a lubricant during the manufacturing process and has been determined to be biocompatible.Devices with silicone found in the packaging can continue to be used and pose no risk to the patient.The evaluations confirms the photographic evidence of a damaged shelf carton.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The reported event of foreign matter is not confirmed, the substance observed and found to be present was determined to be silicone that migrated within the device packaging.It was not a foreign matter and was no nonconformity of the device observed.Reference complaint #(b)(4); record id (b)(4).

Event Description

It was reported that prior to use of the intra-aortic balloon (iab), the user carton was damaged and moisture was observed inside of the product tray.There was no patient involvement.

• 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: 8568562
• MDR Text Key: 143681106
• Report Number: 2248146-2019-00401
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 04/17/2019
• Device Age: YR
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1