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

Catalog Number 0684-00-0475

Device Problems Moisture Damage (1405); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The iab insertion kit was returned unused sealed and intact. Fluid was found on the tray and pouch. The evaluation consisted of a visual inspection confirming the presence of fluid inside the device packaging. This fluid appearance is visually consistent with samples that have been tested via infrared spectrum analysis and found to be silicone. 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. A lot history record review was completed for the reported product. No nonconformances were found that are considered to be related to the event. (b)(4).

Event Description

It was reported by the customer there was moisture found inside of the intra-aortic balloon (iab) insertion kit. This was found prior to use on patient and therefore no patient involvement. The date of the event is unknown.

Manufacturer Narrative

The iab insertion kit was returned unused sealed and intact. Fluid was found on the tray and pouch. The evaluation consisted of a visual inspection confirming the presence of fluid inside the device packaging. A sample of the fluid has been tested via infrared spectrum analysis. The infra-red spectrophotometer results confirmed that the substance was silicone 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. A lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. The reported event has been confirmed, there was no malfunction of the reported devices. Complaint # (b)(4).

Event Description

It was reported by the customer there was moisture found inside of the intra-aortic balloon (iab) insertion kit. This was found prior to use on patient and therefore no patient involvement. The date of the event is unknown.

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 by the customer there was moisture found inside of the intra-aortic balloon (iab) insertion kit. This was found prior to use on patient and therefore no patient involvement. The date of the event is unknown.

• Brand Name: LINEAR 7.5 FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: 15 law drive; fairfield, NJ 07004
• MDR Report Key: 6905995
• MDR Text Key: 250906970
• Report Number: 2248146-2017-00426
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000051291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage