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

Catalog Number 0684-00-0475

Device Problem Material Rupture (1546)

Patient Problem Myocardial Infarction (1969)

Event Date 05/15/2016

Event Type  malfunction  

Manufacturer Narrative

A device and lot history record review and trend evaluation was completed for the reported product.No nonconformances were found that are considered to be related to the event.Evaluation of the affected device could not be performed since it was not returned, the complaint could not be confirmed.When its' provided we will send a supplemental report with additional findings.We continue in our efforts to follow up with the customer for its' return.(b)(4).

Event Description

Post balloon rupture patients inotropic requirements had to be increased as he was dependant on support (mechanical + chemical) from his myocardial stunning episodes.Iab was replaced.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and within the stat-guard sleeve.The extension tubing was also returned.No blood was observed inside the iab catheter.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extension tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.(b)(4).

Event Description

Post balloon rupture patients inotropic requirements had to be increased as he was dependant on support (mechanical + chemical) from his myocardial stunning episodes.Iab was replaced.

Manufacturer Narrative

Correction: date was not entered in the initial mdr.Manufacturer date: 05/16/2016.

Event Description

Post balloon rupture patients inotropic requirements had to be increased as he was dependant on support (mechanical + chemical) from his myocardial stunning episodes.Iab was replaced.

• 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: 5722512
• MDR Text Key: 47295779
• Report Number: 2248146-2016-00048
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K943896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2018
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000008080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2015
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 72 YR