MAUDE Adverse Event Report: DATASCOPE FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

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 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.We continue our efforts to follow up for its return.(b)(4).

Event Description

It was reported that 18 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)(6).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 7 of 18 of the devices.

Manufacturer Narrative

Despite our good faith efforts, 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 complaint could not be confirmed.(b)(4).

Event Description

It was reported that 18 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)(6).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 7 of 18 of the devices.

• Brand Name: SENSATION 7FR. 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: 6697758
• MDR Text Key: 79757593
• Report Number: 2248146-2017-00089
• 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: 10/12/2017

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: No Information
• Device Expiration Date: 01/04/2020
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000043013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 10/12/2017
• Date Device Manufactured: 01/04/2017
• 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