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

Catalog Number 0684-00-0567

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

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2017

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 50 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).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 47 of 50 of the devices.

• Brand Name: SENSATION PLUS 7.5FR. 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: 6786171
• MDR Text Key: 82607729
• Report Number: 2248146-2017-00293
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/21/2020
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000047641
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/21/2017
• Date Device Manufactured: 03/21/2017
• 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