MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0433

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

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

The devices have 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.We continue our efforts to follow up for the devices¿ return.(b)(4).

Event Description

It was reported that 35 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside.The packaging is reported to be intact.This was reported by a distributor in (b)(4).The products were not shipped to the end user and therefore there was no patient involvement.This mdr is for 27 of 35 of the devices.

Manufacturer Narrative

A visual inspection confirmed the presence of fluid inside the packaging of the returned device.It was suspected that the fluid was silicone.Devices were sampled and sent for infra-red spectrophotometer (ir) testing.The 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.The event has been confirmed, there was no malfunction of the reported devices.Complaint # (b)(4); record # (b)(4).

Event Description

It was reported that 35 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside.The packaging is reported to be intact.This was reported by a distributor in south africa.The products were not shipped to the end user and therefore there was no patient involvement.This mdr is for 27 of 35 of the devices.

• Brand Name: SENSATION 7FR. 34CC 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: 6698802
• MDR Text Key: 79747112
• Report Number: 2248146-2017-00126
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/07/2019
• Device Catalogue Number: 0684-00-0433
• Device Lot Number: 3000041730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1