MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY 7FR. 34CC IAB - JAPAN; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0513

Device Problems Migration or Expulsion of Device (1395); Difficult to Advance (2920)

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

Event Date 11/24/2017

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 that during intra-aortic balloon (iab) therapy, the iab migrated.When the guidewire was re-inserted in order to correct the iab location, the guidewire was difficult to advance.Replaced iab to continue therapy.No patient injury was reported.

Manufacturer Narrative

Initial reporter: health professional.Distributor- (b)(4).Device evaluation: the product was returned with the membrane completely unfolded and clear fluid on the interior of the catheter.The guide wire was also returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The technician attempted to insert the returned 0.018¿ guide wire through the inner lumen and was able to successfully insert returned guide wire.No obstructions were felt.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.We are unable to confirm the reported iab migration and difficult/unable to advance guide wire because we are unable to mimic the clinical setting.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 that during intra-aortic balloon (iab) therapy, the iab migrated.When the guidewire was re-inserted in order to correct the iab location, the guidewire was difficult to advance.Replaced iab to continue therapy.No patient injury was reported.

• Brand Name: TRANS-RAY 7FR. 34CC IAB - JAPAN
• 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: 7145224
• MDR Text Key: 95907000
• Report Number: 2248146-2017-00736
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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: Health Professional
• Device Expiration Date: 05/09/2019
• Device Catalogue Number: 0684-00-0513
• Device Lot Number: 3000029090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/23/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• 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