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 Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

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 with the customer for its return. (b)(4).

Event Description

It was reported that the intra-aortic balloon has come apart from the t-handle protector and was opened. The customer noted this prior to the procedure and did not use the product. There was no injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter. The sheath was not returned for evaluation. A laboratory insertion test was unable to be performed due to the membrane being unfurled. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. A leak may impact the ability to maintain vacuum. We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. (b)(4).

Event Description

It was reported that the intra-aortic balloon has come apart from the t-handle protector and was opened. The customer noted this prior to the procedure and did not use the product. There was no injury to the patient.

• 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: 6677801
• MDR Text Key: 78830676
• Report Number: 2248146-2017-00063
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 08/02/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/25/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000035406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage