MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0434

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 07/13/2019

Event Type  Injury  

Manufacturer Narrative

Complete initial reporter name - (b)(6).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.Complaint record id # (b)(4).

Event Description

It was reported, that while an intra-aortic balloon (iab) catheter was in use on a patient, a call came in describing a collision between the catheter console and a bed while they were transferring a patient from one room to another.It was stated the tubing broke and could not be connected to the console.The console had been in standby for twenty-eight minutes.The customer initiated manual inflation with a stop-cock and syringe.After aspiration, it was indicated that the catheter was intact and an attempt was made to inflate it, but only 25cc was able to be pushed into a 40cc catheter.The customer connected the catheter to the helium tubing on the console and a second attempt was made, but this was also not successful.The customer was advised to contact the doctor due to a possible issue with the catheter placement.The patient condition deteriorated and they required intubation.When the company representative followed up with the customer 30 minutes later, they were informed that the problem was that the iab catheter extender input connector on the console had been broken off due to a collision with the bed and the console and that the customer was then attempting to inflate the catheter through the wrong port.At the time of the follow up, the patient was reported to be having a computerized tomography (ct) scan done and the catheter had been removed.The insertion was reported to be axillary, which is not the method described in the device instructions for use.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with traces of blood on the exterior of the catheter.Two inner lumen/catheter tubing kinks were observed approximately 34.8cm & 75.9cm from the iab tip.Four additional catheter tubing kinks were observed approximately 43.7cm, 49.8cm, 56.1cm & 60.5cm from the iab tip.Lastly, an optical fiber break was observed approximately 49.3cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump but could not be fully inflated and the check catheter alarm sounded from the pump.The evaluation cannot confirm the reported migration problem since we are unable to mimic the clinical settings.The kinked condition of the catheter tubing restricted gas passage and resulted in a check catheter alarm.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint record # (b)(4).

Event Description

It was reported, that while an intra-aortic balloon (iab) catheter was in use on a patient, a call came in describing a collision between the catheter console and a bed while they were transferring a patient from one room to another.It was stated the tubing broke and could not be connected to the console.The console had been in standby for twenty-eight minutes.The customer initiated manual inflation with a stop-cock and syringe.After aspiration, it was indicated that the catheter was intact and an attempt was made to inflate it, but only 25cc was able to be pushed into a 40cc catheter.The customer connected the catheter to the helium tubing on the console and a second attempt was made, but this was also not successful.The customer was advised to contact the doctor due to a possible issue with the catheter placement.The patient condition deteriorated and they required intubation.When the company representative followed up with the customer 30 minutes later, they were informed that the problem was that the iab catheter extender input connector on the console had been broken off due to a collision with the bed and the console and that the customer was then attempting to inflate the catheter through the wrong port.At the time of the follow up, the patient was reported to be having a computerized tomography (ct) scan done and the catheter had been removed.The insertion was reported to be axillary, which is not the method described in the device instructions for use.

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.Reference complaint # (b)(4).

Event Description

It was reported, that while an intra-aortic balloon (iab) catheter was in use on a patient, a call came in describing a collision between the catheter console and a bed while they were transferring a patient from one room to another.It was stated the tubing broke and could not be connected to the console.The console had been in standby for twenty-eight minutes.The customer initiated manual inflation with a stop-cock and syringe.After aspiration, it was indicated that the catheter was intact and an attempt was made to inflate it, but only 25cc was able to be pushed into a 40cc catheter.The customer connected the catheter to the helium tubing on the console and a second attempt was made, but this was also not successful.The customer was advised to contact the doctor due to a possible issue with the catheter placement.The patient condition deteriorated and they required intubation.When the company representative followed up with the customer 30 minutes later, they were informed that the problem was that the iab catheter extender input connector on the console had been broken off due to a collision with the bed and the console and that the customer was then attempting to inflate the catheter through the wrong port.At the time of the follow up, the patient was reported to be having a computerized tomography (ct) scan done and the catheter had been removed.The insertion was reported to be axillary, which is not the method described in the device instructions for use.

• Brand Name: SENSATION 7FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 8850029
• MDR Text Key: 152908083
• Report Number: 2248146-2019-00643
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2022
• Device Catalogue Number: 0684-00-0434
• Device Lot Number: 3000087225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 83