MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY LINEAR INSERTION KIT FOR USE WITH INTRA-AORTIC BALLOON CATHETERS

Model Number 0684-00-0476

Device Problem Aspiration Issue (2883)

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

Event Date 10/31/2015

Event Type  malfunction  

Event Description

The intra-aortic balloon pump (iabp) catheter was changed out in an icu patient.The catheter came from the manufacturer with a wire in the central lumen.The wire was removed and a wire from the patient was passed through the central lumen of the catheter for placement into the patient.After it was inserted into the patient, i was unable to aspirate any blood from the central lumen.After verifying that the flush line and stopcocks were patent, i tried to aspirate blood directly from the iabp catheter.I was still unable to aspirate blood.The surgeon removed the catheter.I tried aspirating and flushing through the central lumen with a syringe directly on the iabp catheter, i was not able to do so.The patient was now doing fine without the iabp and it was decided to go ahead without the iabp.This is strange in that a wire was in place from the manufacturer, and a wire was passed through the tip of the catheter and out the other end, yet i was unable to move fluid or air through the same lumen.(notes taken from a letter written by the perfusionist.) manufacturer response for insertion kit for use with intra-aortic balloon catheters, maquet (per site reporter): we contacted maquet's complaint department to explain what happened.While reading the perfusionist's remarks i was told not to read anymore.It was explained that the sales rep would need to come by and see if a complaint was warranted, if so they would pick up the product.Then i was given his name and phone number and told to call him for assistance.

• Brand Name: LINEAR INSERTION KIT FOR USE WITH INTRA-AORTIC BALLOON CATHETERS
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; 15 law drive; fairfield NJ 07004
• MDR Report Key: 5238653
• MDR Text Key: 31688993
• Report Number: 5238653
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2020
• Device Model Number: 0684-00-0476
• Device Catalogue Number: 0684-00-0476
• Device Lot Number: 3000003716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1