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 Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

Event Type  malfunction  

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).

Event Description

It was reported during intra-aortic balloon (iab) catheter therapy that there was blood found in tubing.The iab was replaced.There was no harm or injury to the patient.

Manufacturer Narrative

(b)(4).The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and the membrane.The extender tubing, the one way valve, the pressure tubing and the sheath were also returned.One kink was found on the catheter tubing approximately 76.7cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and 1 leak was detected at the membrane rear seal.The evaluation confirmed the reported problem.The reported problem was most likely triggered by a leak which was found at the rear seal of the membrane.The leak likely occurred during therapy since iab catheters are leak tested 100% in manufacturing.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.Complaint # (b)(4); record # (b)(4).

Event Description

It was reported during intra-aortic balloon (iab) catheter therapy that there was blood found in tubing.The iab was replaced.There was no harm or 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: 6725954
• MDR Text Key: 80637876
• Report Number: 2248146-2017-00175
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K041281
• 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
• Report Date: 08/03/2017

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: 12/05/2019
• Device Catalogue Number: 0684-00-0475
• Device Lot Number: 3000041411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 07/01/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 07/20/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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
• Patient Age: 51 YR
• Patient Weight: 60